Femoral Artery Occlusion, Femoral Artery Stenosis, Popliteal Artery Occlusion, Popliteal Artery Stenosis
Conditions
Keywords
Arms, Experimental, Drug Coated Angioplasty Balloon, Active Comparator, Standard Angioplasty Balloon
Brief summary
The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.
Detailed description
The Moxy Drug Coated Balloon is indicated for percutaneous transluminal angioplasty of obstructive de novo or non-stented restenotic lesions in native femoropopliteal arteries up to 15 cm in length and ≥4.0 to ≤6.0 mm in diameter. This study will randomize approximately 476 patients who will receive either the Moxy balloon or standard balloon angioplasty at 55 global investigational sites. Subjects will be blinded to treatment until 12 months and will participate in long term follow-up for 5 years.
Interventions
PROCEDUREStandard Uncoated Angioplasty Balloon
Subjects will be randomized 2:1 to the Moxy Drug Coated Balloon or Standard Angioplasty Balloon
DEVICEMoxy Drug Coated Balloon
Subjects will be randomized 2:1 to the drug coated or standard angioplasty balloon
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All Duplex Ultrasound operators, core lab evaluators, and members of the Clinical Events Committee (CEC) will be blinded to the subject's treatment assignment. Both the subject as well as the Investigator conducting the follow-up visit will be blinded to treatment until the completion of the 12 month visit.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: 1. Male or non-pregnant female ≥18 years of age; 2. Rutherford Clinical Category 2-4; 3. Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen; Angiographic Lesion Inclusion Criteria: 4. Length ≤15 cm; 5. Up to two focal lesions or segments within the designated 15 cm length of vessel may be treated (e.g. two discrete segments, separated by several cm, but both falling within a composite length of ≤15 cm); 6. ≥70% stenosis by visual estimate; 7. Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk; 8. de novo lesion(s) or non-stented restenotic lesion(s) \>90 days from prior angioplasty procedure; 9. Lesion is located at least 3 cm from any stent, if target vessel was previously stented; 10. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix; 11. Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion; 12. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication. 13. At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been revascularized (treatment of outflow disease is NOT permitted during the index procedure); 14. Contralateral limb lesion(s) cannot be treated within 2 weeks before and/or planned 30 days after the protocol treatment in order to avoid confounding complications; 15. No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.
Exclusion criteria
Patients will be excluded if ANY of the following conditions apply: 1. Pregnant or planning on becoming pregnant or men intending to father children; 2. Life expectancy of \<5 years; 3. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in another clinical trial during the follow up period is not allowed. 4. History of hemorrhagic stroke within 3 months; 5. Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure; 6. History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of enrollment; 7. Rutherford Class 0, 1, 5 or 6; 8. Renal failure or chronic kidney disease with modification in diet in renal disease glomerular filtration rate (MDRD GFR) ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis); 9. Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion; 10. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication; 11. Anticipated use of IIb/IIIa inhibitor prior to randomization; 12. Ipsilateral retrograde access; 13. Composite lesion length is \>15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured; 14. Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment; 15. Known inadequate distal outflow (\>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion; 16. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel; 17. Severe calcification that renders the lesion un-dilatable; 18. Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Composite Freedom From All-Cause Peri-Operative (≤30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 12 Months Post Index Procedure | 12 months post index procedure | Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death. |
| Percentage of Participants With Primary Patency of the Target Lesion at 12 Months Post Index Procedure | 12 months post index procedure | Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure | 6, 12, and 24 months post index procedure | Primary Patency is defined as the absence of target lesion restenosis (defined by core lab adjudication or strict application of PSVR thresholds) and freedom from target lesion revascularization (TLR). |
| Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | 6, 12, and 24 months post index procedure | Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) \<2.0 and \<3.0 at 6, 12, and 24 months post index procedure. DUS PSVR was calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase. |
| Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure | 6, 12, and 24 months post index porcedure | DUS Clinical Patency defined as DUS PSVR \<2.5 without prior clinically driven target lesion revascularization (TLR). |
| Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure | 6, 12, and 24 months post index procedure | — |
| Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 6, 12, and 24 months post index procedure | The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 24 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened. |
| Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | 6, 12, and 24 months from baseline | Mean change from baseline values. The Ankle Brachial Index (ABI) is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs. |
| Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline | 6, 12, and 24 months from baseline | The data bellow is presented as a Mean change in scores for the Six Minute Walk Test scores at 6, 12, and 24 months compared to baseline. |
| Number of Acute Device Success at Time of Index Procedure | At time of Index Procedure | Device Success was defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system. |
| Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline. | 6, 12, and 24 months | Mean change from Baseline on the Short Form (SF-36 v2) Quality of Life Questionnaire at 6, 12, and 24 months. The SF-36 v2 United States (US) is a brief measure of general health status. The physical health measure of the test comprises four scales, that is, physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The scores range between 0 and 100 (with higher scores indicating better health). In the results presented below, a positive Mean represents an increase in the average health score while a negative Mean represents a decrease in the same mean score compared to baseline measure. |
| Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline | 6, 12, and 24 months from baseline | Mean change in quality of life (mental component) on Short-form 36 (SF-36 v2) from baseline at 6, 12, and 24 months. The SF-36 v2 United States (US) is a brief measure of general health status. The mental health measure comprises four scales, that is, vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). The scores range from 0 to 100 (with higher scores indicating better health). In the results presented below, a positive Mean represents an increase in the average health score while a negative Mean represents a decrease in the same mean score compared to baseline measure. |
| Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Porcedure | 30 days post index procedure | Number of subjects with Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint) |
| Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 1, 6, 24, 36, 48, and 60 months post index procedure | — |
| Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | 1, 6, 12, 24, 36, 48, and 60 months post index procedure | Amputation defined as above the ankle free survival (AFS). PPI = Post index procedure. |
| Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline. | 6, 12, and 24 months post index procedure | The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 6, 12, and 24 months, compared to baseline assessment scores. |
| Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline. | 6, 12, and 24 months | Mean change in EuroQol (EQ-5D) scores at 6, 12, and 24 months compared to baseline. The EurolQol-5D system rates quality of life using five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of ratings, that is, no problems, slight problems, moderate problems, severe problems and extreme problems that can be selected. A visual scale allows participants to report their own perception of their health status. The overall scores range from 0 (worst) to 100 (best). Please note that the data in the table below represent the mean changes in overall scores for each group compared to their baseline data. |
| Number of Participants With Technical and Procedural Success | At time of Index Procedure | Technical Success is defined as successful access and deployment of the device and visual estimate of ≤30% diameter residual stenosis during the index procedure without deployment of a bailout stent. Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without serious adverse events during the index procedure. |
Countries
Austria, Belgium, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon. | 372 |
| Standard Uncoated Angioplasty Balloon Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon. | 160 |
| Total | 532 |
Baseline characteristics
| Characteristic | Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Standard Uncoated Angioplasty Balloon | Total |
|---|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 10 | 69.0 years STANDARD_DEVIATION 9 | 68.2 years STANDARD_DEVIATION 9.7 |
| Sex: Female, Male Female | 145 Participants | 53 Participants | 198 Participants |
| Sex: Female, Male Male | 227 Participants | 107 Participants | 334 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 64 / 372 | 17 / 160 |
| other Total, other adverse events | 316 / 372 | 126 / 160 |
| serious Total, serious adverse events | 289 / 372 | 125 / 160 |
Outcome results
Primary
Percentage of Participants With Composite Freedom From All-Cause Peri-Operative (≤30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 12 Months Post Index Procedure
Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.
Time frame: 12 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Percentage of Participants With Composite Freedom From All-Cause Peri-Operative (≤30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 12 Months Post Index Procedure | 85.4 Percentage of participants |
| Standard Uncoated Angioplasty Balloon | Percentage of Participants With Composite Freedom From All-Cause Peri-Operative (≤30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 12 Months Post Index Procedure | 79.5 Percentage of participants |
Comparison: To assess if proportion of subjects with at least one safety event\* in the Test group is inferior or not inferior to that of Control group through 12-months Post index procedure (PPI) H0: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically inferior to that of the Control group.~H1: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically non-inferior to that of the Control group.p-value: 0.025Farrington and Manning
Primary
Percentage of Participants With Primary Patency of the Target Lesion at 12 Months Post Index Procedure
Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR).
Time frame: 12 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Percentage of Participants With Primary Patency of the Target Lesion at 12 Months Post Index Procedure | 66.6 Percentage of participants |
| Standard Uncoated Angioplasty Balloon | Percentage of Participants With Primary Patency of the Target Lesion at 12 Months Post Index Procedure | 54.0 Percentage of participants |
Comparison: To assess whether the proportion of subjects with at least one efficacy event\* in the Test group is equal or not to that of Control group through 12-months post-index procedure.~H0: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is equal to that of the Test group.~H1: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is not equal to that of the Test group.p-value: 0.05Chi-squared
Secondary
Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline.
Mean change in EuroQol (EQ-5D) scores at 6, 12, and 24 months compared to baseline. The EurolQol-5D system rates quality of life using five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of ratings, that is, no problems, slight problems, moderate problems, severe problems and extreme problems that can be selected. A visual scale allows participants to report their own perception of their health status. The overall scores range from 0 (worst) to 100 (best). Please note that the data in the table below represent the mean changes in overall scores for each group compared to their baseline data.
Time frame: 6, 12, and 24 months
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline. | 6 months from baseline | 0.08 Score on a scale | Standard Deviation 0.21 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline. | 12 months from baseline | 0.09 Score on a scale | Standard Deviation 0.2 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline. | 24 months from baseline | 0.07 Score on a scale | Standard Deviation 0.23 |
| Standard Uncoated Angioplasty Balloon | Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline. | 6 months from baseline | 0.10 Score on a scale | Standard Deviation 0.18 |
| Standard Uncoated Angioplasty Balloon | Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline. | 12 months from baseline | 0.08 Score on a scale | Standard Deviation 0.2 |
| Standard Uncoated Angioplasty Balloon | Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline. | 24 months from baseline | 0.09 Score on a scale | Standard Deviation 0.2 |
Secondary
Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline
Mean change in quality of life (mental component) on Short-form 36 (SF-36 v2) from baseline at 6, 12, and 24 months. The SF-36 v2 United States (US) is a brief measure of general health status. The mental health measure comprises four scales, that is, vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). The scores range from 0 to 100 (with higher scores indicating better health). In the results presented below, a positive Mean represents an increase in the average health score while a negative Mean represents a decrease in the same mean score compared to baseline measure.
Time frame: 6, 12, and 24 months from baseline
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline | 6 months from baseline | -0.7 score on a scale | Standard Deviation 12 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline | 12 months from baseline | 0.2 score on a scale | Standard Deviation 12.4 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline | 24 months from baseline | -0.4 score on a scale | Standard Deviation 13 |
| Standard Uncoated Angioplasty Balloon | Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline | 6 months from baseline | 1.6 score on a scale | Standard Deviation 14.1 |
| Standard Uncoated Angioplasty Balloon | Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline | 12 months from baseline | 0.4 score on a scale | Standard Deviation 13.4 |
| Standard Uncoated Angioplasty Balloon | Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline | 24 months from baseline | 1.8 score on a scale | Standard Deviation 13.5 |
Secondary
Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline
Mean change from baseline values. The Ankle Brachial Index (ABI) is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs.
Time frame: 6, 12, and 24 months from baseline
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | 6 months post index procedure | 0.20 Index | Standard Deviation 0.24 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | 12 months post index procedure | 0.18 Index | Standard Deviation 0.24 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | 24 months post index procedure | 0.14 Index | Standard Deviation 0.27 |
| Standard Uncoated Angioplasty Balloon | Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | 6 months post index procedure | 0.16 Index | Standard Deviation 0.22 |
| Standard Uncoated Angioplasty Balloon | Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | 12 months post index procedure | 0.18 Index | Standard Deviation 0.25 |
| Standard Uncoated Angioplasty Balloon | Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | 24 months post index procedure | 0.17 Index | Standard Deviation 0.24 |
Secondary
Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline.
Mean change from Baseline on the Short Form (SF-36 v2) Quality of Life Questionnaire at 6, 12, and 24 months. The SF-36 v2 United States (US) is a brief measure of general health status. The physical health measure of the test comprises four scales, that is, physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The scores range between 0 and 100 (with higher scores indicating better health). In the results presented below, a positive Mean represents an increase in the average health score while a negative Mean represents a decrease in the same mean score compared to baseline measure.
Time frame: 6, 12, and 24 months
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline. | 6 months from baseline | 6.6 score on a scale | Standard Deviation 11.4 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline. | 12 months from baseline | 6.0 score on a scale | Standard Deviation 11.4 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline. | 24 months from baseline | 4.5 score on a scale | Standard Deviation 11.2 |
| Standard Uncoated Angioplasty Balloon | Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline. | 6 months from baseline | 6.3 score on a scale | Standard Deviation 10 |
| Standard Uncoated Angioplasty Balloon | Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline. | 12 months from baseline | 5.4 score on a scale | Standard Deviation 10.2 |
| Standard Uncoated Angioplasty Balloon | Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline. | 24 months from baseline | 5.2 score on a scale | Standard Deviation 9.9 |
Secondary
Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline
The data bellow is presented as a Mean change in scores for the Six Minute Walk Test scores at 6, 12, and 24 months compared to baseline.
Time frame: 6, 12, and 24 months from baseline
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline | 6 months from baseline | 42.5 Meters | Standard Deviation 205.7 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline | 12 months from baseline | 45.0 Meters | Standard Deviation 227.5 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline | 24 months from baseline | 48.6 Meters | Standard Deviation 190.6 |
| Standard Uncoated Angioplasty Balloon | Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline | 6 months from baseline | 61.1 Meters | Standard Deviation 213.4 |
| Standard Uncoated Angioplasty Balloon | Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline | 12 months from baseline | 37.4 Meters | Standard Deviation 120 |
| Standard Uncoated Angioplasty Balloon | Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline | 24 months from baseline | 47.1 Meters | Standard Deviation 209.2 |
Secondary
Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline.
The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 6, 12, and 24 months, compared to baseline assessment scores.
Time frame: 6, 12, and 24 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline. | 6 months from baseline | 26.6 score on a scale | Standard Deviation 28.8 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline. | 12 months from baseline | 23.9 score on a scale | Standard Deviation 27.6 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline. | 24 months from baseline | 22.4 score on a scale | Standard Deviation 28.8 |
| Standard Uncoated Angioplasty Balloon | Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline. | 6 months from baseline | 20.5 score on a scale | Standard Deviation 28.7 |
| Standard Uncoated Angioplasty Balloon | Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline. | 12 months from baseline | 19.2 score on a scale | Standard Deviation 26.5 |
| Standard Uncoated Angioplasty Balloon | Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline. | 24 months from baseline | 16.9 score on a scale | Standard Deviation 26.7 |
Secondary
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline
The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 24 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened.
Time frame: 6, 12, and 24 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 6 months from baseline | Same | 30 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 12 months from baseline | Worsened | 9 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 12 months from baseline | Improved | 273 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 24 months from baseline | Improved | 242 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 6 months from baseline | Worsened | 13 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 24 months from baseline | Same | 31 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 12 months from baseline | Same | 27 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 24 months from baseline | Worsened | 7 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 6 months from baseline | Improved | 290 Participants |
| Standard Uncoated Angioplasty Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 24 months from baseline | Worsened | 1 Participants |
| Standard Uncoated Angioplasty Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 6 months from baseline | Improved | 118 Participants |
| Standard Uncoated Angioplasty Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 6 months from baseline | Same | 22 Participants |
| Standard Uncoated Angioplasty Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 6 months from baseline | Worsened | 5 Participants |
| Standard Uncoated Angioplasty Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 12 months from baseline | Improved | 108 Participants |
| Standard Uncoated Angioplasty Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 12 months from baseline | Same | 21 Participants |
| Standard Uncoated Angioplasty Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 12 months from baseline | Worsened | 2 Participants |
| Standard Uncoated Angioplasty Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 24 months from baseline | Improved | 106 Participants |
| Standard Uncoated Angioplasty Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 24 months from baseline | Same | 15 Participants |
Secondary
Number of Acute Device Success at Time of Index Procedure
Device Success was defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.
Time frame: At time of Index Procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Acute Device Success at Time of Index Procedure | 430 Devices |
| Standard Uncoated Angioplasty Balloon | Number of Acute Device Success at Time of Index Procedure | 180 Devices |
Secondary
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI.
Amputation defined as above the ankle free survival (AFS). PPI = Post index procedure.
Time frame: 1, 6, 12, 24, 36, 48, and 60 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 1 month PPI | 0 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 6 months PPI | 4 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 12 months PPI | 10 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 24 months PPI | 25 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 36 months PPI | 37 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 48 months PPI | 54 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 60 months PPI | 64 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 1 month PPI | 0 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 6 months PPI | 1 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 12 months PPI | 1 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 24 months PPI | 1 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 36 months PPI | 1 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 48 months PPI | 2 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 60 months PPI | 2 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 1 month PPI | 0 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 6 months PPI | 0 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 12 months PPI | 0 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 24 months PPI | 1 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 36 months PPI | 2 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 48 months PPI | 3 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 60 months PPI | 3 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 1 month PPI | 362 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 6 months PPI | 349 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 12 months PPI | 331 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 24 months PPI | 301 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 36 months PPI | 283 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 48 months PPI | 261 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 60 months PPI | 242 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 1 month PPI | 1 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 6 months PPI | 20 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 12 months PPI | 38 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 24 months PPI | 59 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 36 months PPI | 69 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 48 months PPI | 78 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 60 months PPI | 85 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 1 month PPI | 1 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 6 months PPI | 22 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 12 months PPI | 42 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 24 months PPI | 63 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 36 months PPI | 73 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 48 months PPI | 83 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 60 months PPI | 90 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 1 month PPI | 1 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 6 months PPI | 1 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 12 months PPI | 1 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 24 months PPI | 1 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 36 months PPI | 2 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 48 months PPI | 2 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 60 months PPI | 2 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 1 month PPI | 1 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 6 months PPI | 20 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 12 months PPI | 31 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 24 months PPI | 52 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 36 months PPI | 55 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 48 months PPI | 55 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 60 months PPI | 55 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 1 month PPI | 15 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 6 months PPI | 19 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 12 months PPI | 22 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 24 months PPI | 32 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 36 months PPI | 36 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 48 months PPI | 39 participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 60 months PPI | 39 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 24 months PPI | 34 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 1 month PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 48 months PPI | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 6 months PPI | 2 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 36 months PPI | 38 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 12 months PPI | 4 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 60 months PPI | 23 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 24 months PPI | 8 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 48 months PPI | 45 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 36 months PPI | 10 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 60 months PPI | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 48 months PPI | 14 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 60 months PPI | 46 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Death : 60 months PPI | 17 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 24 months PPI | 10 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 1 month PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 1 month PPI | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 6 months PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 1 month PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 12 months PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 6 months PPI | 12 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 24 months PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 1 month PPI | 2 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 36 months PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 12 months PPI | 26 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 48 months PPI | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 6 months PPI | 3 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Amputation : 60 months PPI | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 24 months PPI | 39 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 1 month PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 36 months PPI | 13 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 6 months PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 36 months PPI | 43 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 12 months PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 12 months PPI | 10 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 24 months PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 48 months PPI | 53 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 36 months PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 6 months PPI | 4 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 48 months PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TVR : 60 months PPI | 54 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Minor Amputation : 60 months PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 24 months PPI | 21 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 1 month PPI | 156 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 1 month PPI | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 6 months PPI | 152 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 60 months PPI | 13 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 12 months PPI | 144 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 6 months PPI | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 24 months PPI | 133 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 36 months PPI | 23 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 36 months PPI | 129 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 12 months PPI | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 48 months PPI | 122 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 12 months PPI | 7 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Amputation Free Survival : 60 months PPI | 115 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 24 months PPI | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 1 month PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Cardiovascular Hospitalization : 48 months PPI | 23 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 6 months PPI | 9 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Reintervention for Thrombosis : 36 months PPI | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Total TLR : 12 months PPI | 24 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. | Major Vascular Complication : 48 months PPI | 13 participants |
Secondary
Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure
Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) \<2.0 and \<3.0 at 6, 12, and 24 months post index procedure. DUS PSVR was calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.
Time frame: 6, 12, and 24 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | DUS PSVR <2.0 : 6 months post index procedure | 220 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | DUS PSVR <2.0 : 12 months post index procedure | 158 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | DUS PSVR <2.0 : 24 months post index procdure | 106 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | DUS PSVR <3.0 : 6 months post index procedure | 259 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | DUS PSVR <3.0 : 12 months post index procedure | 197 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | DUS PSVR <3.0 : 24 months post index procdure | 131 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | DUS PSVR <3.0 : 12 months post index procedure | 73 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | DUS PSVR <2.0 : 6 months post index procedure | 74 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | DUS PSVR <3.0 : 6 months post index procedure | 98 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | DUS PSVR <2.0 : 12 months post index procedure | 62 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | DUS PSVR <3.0 : 24 months post index procdure | 48 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | DUS PSVR <2.0 : 24 months post index procdure | 38 Participants |
Secondary
Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death
Time frame: 1, 6, 24, 36, 48, and 60 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 1 month post index procedure | 360 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 6 months post index procedure | 324 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 24 months post index procedure | 240 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 36 months post index procedure | 212 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 48 months post index procedure | 189 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 60 months post index procedure | 160 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 48 months post index procedure | 74 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 1 month post index procedure | 155 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 36 months post index procedure | 87 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 6 months post index procedure | 140 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 60 months post index procedure | 69 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death | 24 months post index procedure | 94 Participants |
Secondary
Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure
DUS Clinical Patency defined as DUS PSVR \<2.5 without prior clinically driven target lesion revascularization (TLR).
Time frame: 6, 12, and 24 months post index porcedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure | 6 months post index procedure | 252 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure | 12 months post index procedure | 188 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure | 24 months post index procedure | 123 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure | 6 months post index procedure | 90 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure | 12 months post index procedure | 69 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure | 24 months post index procedure | 42 Participants |
Secondary
Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure
Time frame: 6, 12, and 24 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure | 6 months post index procedure | 329 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure | 12 months post index procedure | 296 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure | 24 months post index procedure | 250 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure | 6 months post index procedure | 144 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure | 12 months post index procedure | 122 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure | 24 months post index procedure | 104 Participants |
Secondary
Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure
Primary Patency is defined as the absence of target lesion restenosis (defined by core lab adjudication or strict application of PSVR thresholds) and freedom from target lesion revascularization (TLR).
Time frame: 6, 12, and 24 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure | 6 months post index procedure | 263 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure | 12 months post index procedure | 209 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure | 24 months post index procedure | 160 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure | 6 months post index procedure | 92 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure | 12 months post index procedure | 74 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure | 24 months post index procedure | 60 Participants |
Secondary
Number of Participants With Technical and Procedural Success
Technical Success is defined as successful access and deployment of the device and visual estimate of ≤30% diameter residual stenosis during the index procedure without deployment of a bailout stent. Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without serious adverse events during the index procedure.
Time frame: At time of Index Procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Technical and Procedural Success | Technical Success | 282 Participants |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Participants With Technical and Procedural Success | Procedural Success | 281 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Technical and Procedural Success | Technical Success | 138 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Technical and Procedural Success | Procedural Success | 138 Participants |
Secondary
Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Porcedure
Number of subjects with Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint)
Time frame: 30 days post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) | Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Porcedure | 361 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Porcedure | 155 Participants |