Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Peripheral Artery Disease
Conditions
Brief summary
The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Interventions
Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.
DEVICEStandard PTA Balloon
Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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 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 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 |
|---|---|
| Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure. | From index procedure to 60 months Post Index Procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | 1, 6, 12, 24, 36, 48, and 60 months post index procedure (PPI) | — |
| Percentage of Participants With Primary Patency of the Target Lesion 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 DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR). |
| 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. |
| 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. |
| Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure | 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 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. |
| 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. |
| Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure | 6, 12, and 24 months post index procedure | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lutonix Drug Coated Balloon Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter
Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries. | 1,029 |
| Standard Uncoated Angioplasty Balloon PTA Catheter
Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries. | 160 |
| Total | 1,189 |
Baseline characteristics
| Characteristic | Lutonix Drug Coated Balloon | Standard Uncoated Angioplasty Balloon | Total |
|---|---|---|---|
| Age, Continuous | 68.4 Years STANDARD_DEVIATION 9.7 | 69.0 Years STANDARD_DEVIATION 9 | 68.48 Years STANDARD_DEVIATION 9.5 |
| Baseline Rutherford Classification Rutherford 0 | 0 Participants | 0 Participants | 0 Participants |
| Baseline Rutherford Classification Rutherford 1 | 0 Participants | 0 Participants | 0 Participants |
| Baseline Rutherford Classification Rutherford 2 | 354 Participants | 55 Participants | 409 Participants |
| Baseline Rutherford Classification Rutherford 3 | 606 Participants | 92 Participants | 698 Participants |
| Baseline Rutherford Classification Rutherford 4 | 69 Participants | 13 Participants | 82 Participants |
| Baseline Rutherford Classification Rutherford 5 | 0 Participants | 0 Participants | 0 Participants |
| Baseline Rutherford Classification Rutherford 6 | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 14 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 988 Participants | 146 Participants | 1134 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 383 Participants | 53 Participants | 436 Participants |
| Sex: Female, Male Male | 646 Participants | 107 Participants | 753 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 147 / 1,029 | 17 / 160 |
| other Total, other adverse events | 845 / 1,029 | 126 / 160 |
| serious Total, serious adverse events | 813 / 1,029 | 125 / 160 |
Outcome results
Primary
Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure.
Time frame: From index procedure to 60 months Post Index Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lutonix Drug Coated Balloon | Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure. | 0 Participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure. | 0 Participants |
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 Drug Coated Balloon | Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | 12 months post index procedure | 0.18 Ratio | Standard Deviation 0.26 |
| Lutonix Drug Coated Balloon | Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | 6 months post index procedure | 0.19 Ratio | Standard Deviation 0.26 |
| Lutonix Drug Coated Balloon | Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | 24-Months Post-Index Procedure | 0.16 Ratio | 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 Ratio | 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 Ratio | 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 Ratio | Standard Deviation 0.24 |
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 Drug Coated Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 6 months from baseline | Improved | 830 Participants |
| Lutonix Drug Coated Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 6 months from baseline | Same | 79 Participants |
| Lutonix Drug Coated Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 6 months from baseline | Worsened | 35 Participants |
| Lutonix Drug Coated Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 12 months from baseline | Improved | 771 Participants |
| Lutonix Drug Coated Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 24 months from baseline | Improved | 701 Participants |
| Lutonix Drug Coated Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 24 months from baseline | Same | 88 Participants |
| Lutonix Drug Coated Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 24 months from baseline | Worsened | 27 Participants |
| Lutonix Drug Coated Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 12 months from baseline | Same | 89 Participants |
| Lutonix Drug Coated Balloon | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 12 months from baseline | Worsened | 30 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 | 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 | 24 months from baseline | Same | 15 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 | 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 | 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 | 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 | 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 | 24 months from baseline | Improved | 106 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
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Lutonix Drug Coated Balloon | Number of Acute Device Success at Time of Index Procedure | 1402 Devices |
| Standard Uncoated Angioplasty Balloon | Number of Acute Device Success at Time of Index Procedure | 180 Devices |
Secondary
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure
Time frame: 1, 6, 12, 24, 36, 48, and 60 months post index procedure (PPI)
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 Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 1 month post index procedure | 0 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 48 months post index procedure | 6 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis : 1 month | 2 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 60 months post index procedure | 8 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 36 months post index procedure | 82 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 1 month post index procedure | 1 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 12 months post index procedure | 1 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis : 6 months | 2 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 24 months post index procedure | 3 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 24 months post index procedure | 2 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 36 months post index procedure | 5 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis : 12 months | 3 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 48 months post index procedure | 9 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 36 months PPI | 830 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 60 months post index procedure | 9 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis : 24 months | 5 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 1 month PPI | 1008 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 6 months post index procedure | 1 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 6 months | 981 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis: 36 months | 7 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 12 months PPI | 949 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 48 months PPI | 776 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 24 months PPI | 881 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 1 month PPI | 6 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis : 48 months | 7 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 6 months PPI | 48 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 24 months PPI | 112 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 12 months PPI | 125 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 36 months post index procedure | 3 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 36 months PPI | 240 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 36 months PPI | 115 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 48 months PPI | 268 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 60 months PPI | 115 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 60 months PPI | 729 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis: 60 months | 8 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 1 month PPI | 27 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 1 month PPI | 6 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 24 months PPI | 79 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 6 months PPI | 53 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 24 months post index procedure | 46 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 12 months PPI | 88 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 1 month post index procedure | 1 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 24 months PPI | 207 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 48 months PPI | 115 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 6 months post index procedure | 8 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 12 months post index procedure | 1 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 6 months PPI | 39 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 12 months post index procedure | 18 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 12 months PPI | 51 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 48 months post index procedure | 121 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 36 months PPI | 87 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 60 months PPI | 283 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 48 months PPI | 92 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 60 months post index procedure | 147 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 60 months PPI | 93 participants |
| Lutonix Drug Coated Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 6 months post index procedure | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 60 months PPI | 13 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 24 months post index procedure | 8 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 36 months post index procedure | 10 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 1 month post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 6 months post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 12 months post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 24 months post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 36 months post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 1 month post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 6 months post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 24 months PPI | 133 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 36 months PPI | 129 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 48 months PPI | 122 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 60 months PPI | 115 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 24 months PPI | 39 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 60 months PPI | 54 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis : 1 month | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis : 6 months | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis : 12 months | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis : 24 months | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis: 36 months | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 24 months PPI | 21 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 60 months PPI | 23 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 24 months PPI | 10 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 1 month post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 6 months post index procedure | 2 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 48 months post index procedure | 14 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 60 months post index procedure | 17 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 48 months post index procedure | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Amputation : 60 months post index procedure | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 12 months post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 24 months post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 36 months post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 48 months post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Minor Amputation : 60 months post index procedure | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 1 month PPI | 156 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 6 months | 152 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Amputation Free Survival : 12 months PPI | 144 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 1 month PPI | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 6 months PPI | 12 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 12 months PPI | 26 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 36 months PPI | 43 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Target Vessel Revascularization : 48 months PPI | 53 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis : 48 months | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Reintervention for thrombosis: 60 months | 1 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 1 month PPI | 0 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 6 months PPI | 3 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 12 months PPI | 10 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 36 months PPI | 23 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Cardiovascular Hospitalization : 48 months PPI | 23 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 1 month PPI | 2 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 6 months PPI | 4 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 12 months PPI | 71 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 36 months PPI | 13 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Major Vascular Complications : 48 months PPI | 13 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | Death : 12 months post index procedure | 4 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 Drug Coated 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 | 400 Participants |
| Lutonix Drug Coated 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 procedure | 282 Participants |
| Lutonix Drug Coated 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 | 670 Participants |
| Lutonix Drug Coated 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 | 492 Participants |
| Lutonix Drug Coated 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 | 565 Participants |
| Lutonix Drug Coated 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 procedure | 344 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 procedure | 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: 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 >=2.0: 24 months post index procedure | 38 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: 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 >=3.0: 12 months post index procedure | 73 Participants |
Secondary
Number of Participants With Freedom From Target Lesion Revascularization (TLR) 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 Drug Coated Balloon | Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure | 6 months post index procedure | 940 participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure | 12 months post index procedure | 839 participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure | 24-Months Post-Index Procedure | 706 participants |
| Standard Uncoated Angioplasty Balloon | Number of Participants With Freedom From Target Lesion Revascularization (TLR) 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) 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) at 6, 12, and 24 Months Post Index Procedure | 24-Months Post-Index Procedure | 104 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 Drug Coated Balloon | Number of Participants With Technical and Procedural Success | Technical Success | 894 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Technical and Procedural Success | Procedural Success | 892 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 Procedure
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 Drug Coated Balloon | Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure | 1002 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 Procedure | 155 Participants |
Secondary
Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 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: 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 Drug Coated Balloon | Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure | 24 months post index procedure | 54.5 Percentage of Participants |
| Lutonix Drug Coated Balloon | Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure | 6 months post index procedure | 81.4 Percentage of Participants |
| Lutonix Drug Coated Balloon | Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure | 12 months post index procedure | 66.3 Percentage of Participants |
| Standard Uncoated Angioplasty Balloon | Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure | 24 months post index procedure | 47.2 Percentage of Participants |
| Standard Uncoated Angioplasty Balloon | Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure | 6 months post index procedure | 64.8 Percentage of Participants |
| Standard Uncoated Angioplasty Balloon | Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure | 12 months post index procedure | 54.0 Percentage of Participants |