Critical Limb Ischemia
Conditions
Brief summary
To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
Interventions
DEVICELutonix DCB
DEVICEUncoated PTA Catheter
Sponsors
Bard Ltd
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant female ≥18 years of age; * Rutherford Clinical Category 3, 4 & 5; * Life expectancy ≥ 1 year; * Significant stenosis (≥70%) * A patent inflow artery; * Target vessel(s) diameter between 2 and 4 mm; * Target vessel(s) reconstitute(s) at or above the ankle
Exclusion criteria
* Pregnant or planning on becoming pregnant; * History of stroke within 3 months; * History of MI, thrombolysis or angina within 30 days of enrollment; * Planned major amputation (of either leg) * Prior major amputation if amputation occurred less than one year prior to enrollment and if patient is not independently ambulating; * GFR ≤ 30 ml/min per 1.73m2; * Acute limb ischemia; * In-stent restenosis of target lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Freedom From Below-the-Knee (BTK) Major Adverse Limb Event and Peri-Operative Death (POD) at 30 Days Post Index Procedure. | 30 days post index procedure | The primary safety endpoint is defined as freedom from the composite of all-cause death, above-ankle amputation or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a below-the-knee artery. |
| Number of Participants With Freedom From the Composite of Above-ankle Amputation, Target Lesion Occlusion, and Clinically-driven Target Lesion Revascularization at 6 Months Post Index Procedure. | 6 months post-index procedure | The primary efficacy endpoint is defined as freedom from the composite of above-ankle amputation, target lesion occlusion, and clinically-driven target lesion revascularization. All amputations included in endpoints refer to amputations in the index limb. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the Below the Knee (BTK) Major Adverse Limb Event (MALE) and Perioperative Death (POD) Rate to a Performance Goal at 30 Days Post Index Procedure. | 30 days post index procedure | — |
| Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline. | 30 days, 6 and 12 months post index procedure compared to baseline | Mean change in EuroQol (EQ-5D) scores at 30 days, 6, and 12 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. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Late Lumen Loss at 12 Months Post Index Procedure | 12 months post-index procedure | — |
| Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure | 30 days, 6 and 12 months post index procedure | Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. The number of wounds analyzed at 6 and 12 months post-index procedure includes wounds that may have appeared (new wounds) since the previous time period reporting. |
| Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 30 days, 6 and 12 months post index procedure | — |
| Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 30 days, 6 and 12 months post index procedure | Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 30 days, 6 and 12 months post index procedure compared to baseline | The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 36 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 30 days, 6 and 12 months post index procedure | The composite endpoint of freedom from above ankle amputation (CEC-adjudicated), unhealed wound (presence of wound vs. no wound), ischemic rest pain (Rutherford category 4 or higher), target vessel occlusion (based on DUS and/or angiograph), and clinically-driven TVR (CEC-adjudicated). Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure | 30 days and at 6 and 12 months | Primary patency is defined as the absence of both total occlusion (100% diameter stenosis) in all of the target lesions in a flow pathway as well as a clinically-driven Target Lesion Revascularization (TLR). Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure | 30 days, 6 and 12 months post index procedure | Primary patency with exclusion of early mechanical recoil of the target flow pathway is defined as the absence of both total occlusion (100% diameter stenosis) of the target lesions and clinically-driven TLR events \> 30 days. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure | 30 days, 6 and 12 months post index procedure | The secondary patency of the target lesion is defined as the absence of total occlusion (100% diameter stenosis) of the target lesions based on angiography (if performed) or ultrasound as analyzed by the angiographic Core Lab. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Percentage of Lesions Considered Technical Success at Time of Index Procedure | At time of index procedure | Technical Success: A success is determined if the device success was achieved and a final residual stenosis post study device (DCB or placebo) dilatation ≤ 30% was reported. |
| Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 30 days, 6 and 12 months post index procedure compared to baseline | Mean change from baseline values. The Toe Brachial Index (TBI) is defined as a ratio of toe to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 30 days, and at 6 and 12 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. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 30 days, 6 and 12 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 30 days 6 and 12 months, compared to baseline assessment scores. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Number of Participants With Clinically-Driven Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure | 30 days, 6 and 12 months post index procedure | — |
| Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure. | 30 days, 6 and 12 months post index procedure | Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Number of Participants With Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 30 days, 6 and 12 months post index procedure | — |
| Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 30 days, 6 and 12 months post index procedure | — |
| Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure | 30 days and at 6 and 12 months | Limb salvage defined as no amputation of target limb. |
| Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure. | 30 days, 6 and 12 months post index procedure | Defined as amputation that was below the ankle, including digit amputation. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure. | 30 days, 6 and 12 months post index procedure | The overall burden of BTK reinterventions was defined as the total number of BTK index-limb re-interventions and major amputations for each time point. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure | 30 days, 6 and 12 months post index procedure | Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. |
| Composite of Freedom From Clinically -Driven Target Lesion Revascularization (TLR) and From 50% DS by Angiography or Duplex Ultrasound at 30 Days, 6 and 12 Months Post Index Procedure. | 30 days, 6 and 12 months post index procedure | — |
| Percentage of Procedures With Procedural Success at Time of Index Procedure. | At time of Index Procedure | A success is determined if there is restoration of at least 1 infrapopliteal artery with residual stenosis ≤ 30% (or ≤ 50% depending upon the version of the protocol) and inline outflow to the foot, irrespective of device success, and without a major adverse event during the index procedure. |
Countries
Austria, Belgium, Canada, Germany, Italy, Japan, Switzerland, United States
Participant flow
Recruitment details
Participants were recruited from medical clinics and hospitals between June 2013 and January 2018. The first participant was enrolled on June 3, 2013 and the last participant enrolled was on December 12, 2017.
Participants by arm
| Arm | Count |
|---|---|
| Lutonix DCB Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon.
Lutonix DCB
Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. | 287 |
| Standard Balloon Angioplasty Catheter Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Standard Balloon Angioplasty Catheter
Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. | 155 |
| Total | 442 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 48 | 24 |
| Overall Study | Lost to Follow-up | 19 | 14 |
| Overall Study | On-going in the Study | 35 | 25 |
| Overall Study | Other | 9 | 7 |
| Overall Study | Withdrawal by Subject | 39 | 26 |
Baseline characteristics
| Characteristic | Standard Balloon Angioplasty Catheter | Lutonix DCB | Total |
|---|---|---|---|
| Age, Continuous | 72.9 years STANDARD_DEVIATION 9.62 | 72.9 years STANDARD_DEVIATION 9.65 | 72.9 years STANDARD_DEVIATION 9.63 |
| Body Mass Index | 28.0 kg/m^2 STANDARD_DEVIATION 5.65 | 28.4 kg/m^2 STANDARD_DEVIATION 6.31 | 28.2 kg/m^2 STANDARD_DEVIATION 6.08 |
| Height | 170 cm STANDARD_DEVIATION 10.65 | 170 cm STANDARD_DEVIATION 10.07 | 170 cm STANDARD_DEVIATION 10.26 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 15 Participants | 25 Participants | 40 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants | 33 Participants | 45 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 127 Participants | 226 Participants | 353 Participants |
| Region of Enrollment Canada | 1 participants | 4 participants | 5 participants |
| Region of Enrollment Europe | 42 participants | 80 participants | 122 participants |
| Region of Enrollment Japan | 15 participants | 25 participants | 40 participants |
| Region of Enrollment United States | 97 participants | 178 participants | 275 participants |
| Sex: Female, Male Female | 51 Participants | 85 Participants | 136 Participants |
| Sex: Female, Male Male | 104 Participants | 202 Participants | 306 Participants |
| Weight | 81.9 kg STANDARD_DEVIATION 20.29 | 82.6 kg STANDARD_DEVIATION 21.15 | 82.3 kg STANDARD_DEVIATION 20.83 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 48 / 287 | 25 / 155 |
| other Total, other adverse events | 106 / 287 | 45 / 155 |
| serious Total, serious adverse events | 240 / 287 | 126 / 155 |
Outcome results
Primary
Number of Participants With Freedom From Below-the-Knee (BTK) Major Adverse Limb Event and Peri-Operative Death (POD) at 30 Days Post Index Procedure.
The primary safety endpoint is defined as freedom from the composite of all-cause death, above-ankle amputation or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a below-the-knee artery.
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 DCB | Number of Participants With Freedom From Below-the-Knee (BTK) Major Adverse Limb Event and Peri-Operative Death (POD) at 30 Days Post Index Procedure. | 284 Participants |
| PTA Catheter | Number of Participants With Freedom From Below-the-Knee (BTK) Major Adverse Limb Event and Peri-Operative Death (POD) at 30 Days Post Index Procedure. | 154 Participants |
Comparison: The primary safety hypothesis is as follows: H0: pControl - pDCB ≥ and H1: pControl (alpha) pDCB \< where p is the success rate in each arm and (alpha) is the non-inferiority bound.p-value: <0.025Farrington and Manning
Primary
Number of Participants With Freedom From the Composite of Above-ankle Amputation, Target Lesion Occlusion, and Clinically-driven Target Lesion Revascularization at 6 Months Post Index Procedure.
The primary efficacy endpoint is defined as freedom from the composite of above-ankle amputation, target lesion occlusion, and clinically-driven target lesion revascularization. All amputations included in endpoints refer to amputations in the index limb.
Time frame: 6 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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lutonix DCB | Number of Participants With Freedom From the Composite of Above-ankle Amputation, Target Lesion Occlusion, and Clinically-driven Target Lesion Revascularization at 6 Months Post Index Procedure. | 201 Participants |
| PTA Catheter | Number of Participants With Freedom From the Composite of Above-ankle Amputation, Target Lesion Occlusion, and Clinically-driven Target Lesion Revascularization at 6 Months Post Index Procedure. | 88 Participants |
p-value: 0.0222Wald Test
Secondary
Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure 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. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, and at 6 and 12 months compared to 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 DCB | Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 30-days Post Index Procedure | 0.23 Ratio | Standard Deviation 0.36 |
| Lutonix DCB | Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 6 months post index procedure | 0.16 Ratio | Standard Deviation 0.36 |
| Lutonix DCB | Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 12 months post index procedure | 0.11 Ratio | Standard Deviation 0.36 |
| PTA Catheter | Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 30-days Post Index Procedure | 0.28 Ratio | Standard Deviation 0.42 |
| PTA Catheter | Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 6 months post index procedure | 0.17 Ratio | Standard Deviation 0.43 |
| PTA Catheter | Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 12 months post index procedure | 0.18 Ratio | Standard Deviation 0.4 |
Secondary
Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline.
Mean change in EuroQol (EQ-5D) scores at 30 days, 6, and 12 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. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, 6 and 12 months post index procedure compared to 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 DCB | Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline. | 30-days Post Index Procedure | 1.10 Scores on a scale | Standard Deviation 0.458 |
| Lutonix DCB | Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline. | 6 months post index procedure | 0.07 Scores on a scale | Standard Deviation 0.3 |
| Lutonix DCB | Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline. | 12 months post index procedure | 0.09 Scores on a scale | Standard Deviation 0.284 |
| PTA Catheter | Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline. | 30-days Post Index Procedure | 0.53 Scores on a scale | Standard Deviation 0.533 |
| PTA Catheter | Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline. | 6 months post index procedure | 0.05 Scores on a scale | Standard Deviation 0.297 |
| PTA Catheter | Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline. | 12 months post index procedure | 0.12 Scores on a scale | Standard Deviation 0.267 |
Secondary
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.
The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 36 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, 6 and 12 months post index procedure compared to 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 | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lutonix DCB | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 12 months post index procedure | Worsened | 5 Participants |
| Lutonix DCB | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 30-days Post Index Procedure | Improved | 161 Participants |
| Lutonix DCB | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 30-days Post Index Procedure | Same | 100 Participants |
| Lutonix DCB | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 30-days Post Index Procedure | Worsened | 2 Participants |
| Lutonix DCB | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 6 months post index procedure | Improved | 179 Participants |
| Lutonix DCB | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 6 months post index procedure | Same | 58 Participants |
| Lutonix DCB | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 6 months post index procedure | Worsened | 6 Participants |
| Lutonix DCB | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 12 months post index procedure | Improved | 176 Participants |
| Lutonix DCB | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 12 months post index procedure | Same | 39 Participants |
| PTA Catheter | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 12 months post index procedure | Improved | 90 Participants |
| PTA Catheter | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 6 months post index procedure | Same | 21 Participants |
| PTA Catheter | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 30-days Post Index Procedure | Improved | 83 Participants |
| PTA Catheter | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 12 months post index procedure | Worsened | 4 Participants |
| PTA Catheter | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 30-days Post Index Procedure | Same | 59 Participants |
| PTA Catheter | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 6 months post index procedure | Worsened | 1 Participants |
| PTA Catheter | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 30-days Post Index Procedure | Worsened | 2 Participants |
| PTA Catheter | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 12 months post index procedure | Same | 16 Participants |
| PTA Catheter | Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 6 months post index procedure | Improved | 98 Participants |
Secondary
Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline
Mean change from baseline values. The Toe Brachial Index (TBI) is defined as a ratio of toe to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, 6 and 12 months post index procedure compared to 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 DCB | Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 30-days Post Index Procedure | 0.20 Ratio | Standard Deviation 0.25 |
| Lutonix DCB | Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 6 months post index procedure | 0.15 Ratio | Standard Deviation 0.24 |
| Lutonix DCB | Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 12 months post index procedure | 0.12 Ratio | Standard Deviation 0.23 |
| PTA Catheter | Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 30-days Post Index Procedure | 0.28 Ratio | Standard Deviation 0.42 |
| PTA Catheter | Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 6 months post index procedure | 0.17 Ratio | Standard Deviation 0.43 |
| PTA Catheter | Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline | 12 months post index procedure | 0.18 Ratio | Standard Deviation 0.4 |
Secondary
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 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 30 days 6 and 12 months, compared to baseline assessment scores. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, 6 and 12 months post index procedure compared to 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 DCB | Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 30-days Post Index Procedure | 0.3 score on a scale | Standard Deviation 18.13 |
| Lutonix DCB | Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 6 months post index procedure | 2.9 score on a scale | Standard Deviation 21.55 |
| Lutonix DCB | Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 12 months post index procedure | 2.7 score on a scale | Standard Deviation 22.1 |
| PTA Catheter | Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 30-days Post Index Procedure | 1.1 score on a scale | Standard Deviation 17.46 |
| PTA Catheter | Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 6 months post index procedure | 3.6 score on a scale | Standard Deviation 20.27 |
| PTA Catheter | Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. | 12 months post index procedure | 2.3 score on a scale | Standard Deviation 20.23 |
Secondary
Comparison of the Below the Knee (BTK) Major Adverse Limb Event (MALE) and Perioperative Death (POD) Rate to a Performance Goal at 30 Days Post Index Procedure.
Time frame: 30 days post index procedure
Population: Data were not collected.
Secondary
Composite of Freedom From Clinically -Driven Target Lesion Revascularization (TLR) and From 50% DS by Angiography or Duplex Ultrasound at 30 Days, 6 and 12 Months Post Index Procedure.
Time frame: 30 days, 6 and 12 months post index procedure
Population: Data were not collected.
Secondary
Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure.
The overall burden of BTK reinterventions was defined as the total number of BTK index-limb re-interventions and major amputations for each time point. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, 6 and 12 months post index procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | 27 Limb Reintervention |
| Lutonix DCB | Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | 112 Limb Reintervention |
| Lutonix DCB | Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | 235 Limb Reintervention |
| PTA Catheter | Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | 22 Limb Reintervention |
| PTA Catheter | Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | 88 Limb Reintervention |
| PTA Catheter | Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | 124 Limb Reintervention |
Secondary
Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure.
Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, 6 and 12 months post index procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | 5 participants |
| Lutonix DCB | Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | 36 participants |
| Lutonix DCB | Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | 101 participants |
| PTA Catheter | Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | 6 participants |
| PTA Catheter | Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | 36 participants |
| PTA Catheter | Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | 53 participants |
Secondary
Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
Time frame: 30 days, 6 and 12 months post index procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | 5 Target Vessel Revascualarization |
| Lutonix DCB | Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | 37 Target Vessel Revascualarization |
| Lutonix DCB | Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | 105 Target Vessel Revascualarization |
| PTA Catheter | Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | 57 Target Vessel Revascualarization |
| PTA Catheter | Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | 6 Target Vessel Revascualarization |
| PTA Catheter | Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | 38 Target Vessel Revascualarization |
Secondary
Late Lumen Loss at 12 Months Post Index Procedure
Time frame: 12 months post-index procedure
Population: Data were not collected.
Secondary
Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure
Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. The number of wounds analyzed at 6 and 12 months post-index procedure includes wounds that may have appeared (new wounds) since the previous time period reporting.
Time frame: 30 days, 6 and 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 | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Lutonix DCB | Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure | 30-days Post Index Procedure | 49 Wounds |
| Lutonix DCB | Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure | 6 months post index procedure | 61 Wounds |
| Lutonix DCB | Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure | 12 months post index procedure | 42 Wounds |
| PTA Catheter | Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure | 30-days Post Index Procedure | 24 Wounds |
| PTA Catheter | Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure | 6 months post index procedure | 45 Wounds |
| PTA Catheter | Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure | 12 months post index procedure | 17 Wounds |
Secondary
Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure
The secondary patency of the target lesion is defined as the absence of total occlusion (100% diameter stenosis) of the target lesions based on angiography (if performed) or ultrasound as analyzed by the angiographic Core Lab. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, 6 and 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 | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure | 30-days Post Index Procedure | 284 Lesions |
| Lutonix DCB | Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure | 6 months post index procedure | 217 Lesions |
| Lutonix DCB | Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure | 12 months post index procedure | 144 Lesions |
| PTA Catheter | Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure | 30-days Post Index Procedure | 146 Lesions |
| PTA Catheter | Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure | 6 months post index procedure | 103 Lesions |
| PTA Catheter | Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure | 12 months post index procedure | 91 Lesions |
Secondary
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure.
Time frame: 30 days, 6 and 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 | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Lutonix DCB | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 30-days Post Index Procedure | Stagnant | 24 Non-Healed Wounds |
| Lutonix DCB | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 6 months post index procedure | Worsening | 12 Non-Healed Wounds |
| Lutonix DCB | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 6 months post index procedure | Improving | 26 Non-Healed Wounds |
| Lutonix DCB | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 12 months post index procedure | Improving | 18 Non-Healed Wounds |
| Lutonix DCB | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 30-days Post Index Procedure | Worsening | 16 Non-Healed Wounds |
| Lutonix DCB | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 12 months post index procedure | Stagnant | 9 Non-Healed Wounds |
| Lutonix DCB | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 6 months post index procedure | Stagnant | 13 Non-Healed Wounds |
| Lutonix DCB | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 12 months post index procedure | Worsening | 1 Non-Healed Wounds |
| Lutonix DCB | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 30-days Post Index Procedure | Improving | 90 Non-Healed Wounds |
| PTA Catheter | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 12 months post index procedure | Worsening | 2 Non-Healed Wounds |
| PTA Catheter | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 30-days Post Index Procedure | Improving | 37 Non-Healed Wounds |
| PTA Catheter | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 30-days Post Index Procedure | Stagnant | 16 Non-Healed Wounds |
| PTA Catheter | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 30-days Post Index Procedure | Worsening | 8 Non-Healed Wounds |
| PTA Catheter | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 6 months post index procedure | Improving | 6 Non-Healed Wounds |
| PTA Catheter | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 6 months post index procedure | Stagnant | 7 Non-Healed Wounds |
| PTA Catheter | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 6 months post index procedure | Worsening | 4 Non-Healed Wounds |
| PTA Catheter | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 12 months post index procedure | Improving | 8 Non-Healed Wounds |
| PTA Catheter | Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. | 12 months post index procedure | Stagnant | 4 Non-Healed Wounds |
Secondary
Number of Participants With Clinically-Driven Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure
Time frame: 30 days, 6 and 12 months post index procedure
Population: Data were not collected.
Secondary
Number of Participants With Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
Time frame: 30 days, 6 and 12 months post index procedure
Population: Data were not collected.
Secondary
Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
The composite endpoint of freedom from above ankle amputation (CEC-adjudicated), unhealed wound (presence of wound vs. no wound), ischemic rest pain (Rutherford category 4 or higher), target vessel occlusion (based on DUS and/or angiograph), and clinically-driven TVR (CEC-adjudicated). Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, 6 and 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 | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lutonix DCB | Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | 98 Participants |
| Lutonix DCB | Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | 93 Participants |
| Lutonix DCB | Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | 71 Participants |
| PTA Catheter | Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | 49 Participants |
| PTA Catheter | Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | 45 Participants |
| PTA Catheter | Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | 53 Participants |
Secondary
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure.
Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, 6 and 12 months post index procedure
Population: Participants may have more than one wound type or wounds in more than one location. 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_UNITS) |
|---|---|---|---|---|
| Lutonix DCB | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | New Wounds | 20 Wounds |
| Lutonix DCB | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | Recurrent Wounds | 1 Wounds |
| Lutonix DCB | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | Recurrent Wounds | 1 Wounds |
| Lutonix DCB | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | Existing Wounds | 37 Wounds |
| Lutonix DCB | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | New Wounds | 5 Wounds |
| Lutonix DCB | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | New Wounds | 9 Wounds |
| Lutonix DCB | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | Existing Wounds | 62 Wounds |
| Lutonix DCB | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | Recurrent Wounds | 4 Wounds |
| Lutonix DCB | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | Existing Wounds | 94 Wounds |
| PTA Catheter | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | Recurrent Wounds | 1 Wounds |
| PTA Catheter | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | Existing Wounds | 46 Wounds |
| PTA Catheter | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | New Wounds | 12 Wounds |
| PTA Catheter | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | Recurrent Wounds | 0 Wounds |
| PTA Catheter | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | Existing Wounds | 33 Wounds |
| PTA Catheter | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | New Wounds | 10 Wounds |
| PTA Catheter | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | Existing Wounds | 16 Wounds |
| PTA Catheter | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | New Wounds | 9 Wounds |
| PTA Catheter | Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | Recurrent Wounds | 1 Wounds |
Secondary
Percentage of Lesions Considered Technical Success at Time of Index Procedure
Technical Success: A success is determined if the device success was achieved and a final residual stenosis post study device (DCB or placebo) dilatation ≤ 30% was reported.
Time frame: At time of index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lutonix DCB | Percentage of Lesions Considered Technical Success at Time of Index Procedure | 61.3 percentage of lesions |
| PTA Catheter | Percentage of Lesions Considered Technical Success at Time of Index Procedure | 58.3 percentage of lesions |
Secondary
Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure
Primary patency with exclusion of early mechanical recoil of the target flow pathway is defined as the absence of both total occlusion (100% diameter stenosis) of the target lesions and clinically-driven TLR events \> 30 days. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, 6 and 12 months post index procedure
Population: The number of participants or lesions may vary depending on the number of participants/lesions for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure | 30-days Post Index Procedure | 100 Percentage of Lesions |
| Lutonix DCB | Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure | 6 months post index procedure | 88.0 Percentage of Lesions |
| Lutonix DCB | Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure | 12 months post index procedure | 61.7 Percentage of Lesions |
| PTA Catheter | Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure | 30-days Post Index Procedure | 100 Percentage of Lesions |
| PTA Catheter | Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure | 6 months post index procedure | 73.8 Percentage of Lesions |
| PTA Catheter | Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure | 12 months post index procedure | 63.0 Percentage of Lesions |
Secondary
Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure
Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, 6 and 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 | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure | 30-days Post Index Procedure | 93.4 Percentage of participants |
| Lutonix DCB | Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure | 6 months post index procedure | 78.9 Percentage of participants |
| Lutonix DCB | Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure | 12 months post index procedure | 56.8 Percentage of participants |
| PTA Catheter | Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure | 30-days Post Index Procedure | 90.3 Percentage of participants |
| PTA Catheter | Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure | 6 months post index procedure | 69.6 Percentage of participants |
| PTA Catheter | Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure | 12 months post index procedure | 58.0 Percentage of participants |
Secondary
Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure
Limb salvage defined as no amputation of target limb.
Time frame: 30 days and at 6 and 12 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 (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure | 30-days Post Index Procedure | 100 percentage of participants |
| Lutonix DCB | Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure | 6 months post index procedure | 98.9 percentage of participants |
| Lutonix DCB | Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure | 12 months post index procedure | 97.4 percentage of participants |
| PTA Catheter | Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure | 30-days Post Index Procedure | 100 percentage of participants |
| PTA Catheter | Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure | 6 months post index procedure | 98.0 percentage of participants |
| PTA Catheter | Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure | 12 months post index procedure | 98.0 percentage of participants |
Secondary
Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure
Primary patency is defined as the absence of both total occlusion (100% diameter stenosis) in all of the target lesions in a flow pathway as well as a clinically-driven Target Lesion Revascularization (TLR). Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days and at 6 and 12 months
Population: The number of participants or lesions may vary depending on the number of participants/lesions for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure | 30-days Post Index Procedure | 97.4 Percentage of Participants |
| Lutonix DCB | Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure | 6 months post index procedure | 85.3 Percentage of Participants |
| Lutonix DCB | Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure | 12 months post procedure | 58.1 Percentage of Participants |
| PTA Catheter | Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure | 30-days Post Index Procedure | 94.8 Percentage of Participants |
| PTA Catheter | Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure | 6 months post index procedure | 72.2 Percentage of Participants |
| PTA Catheter | Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure | 12 months post procedure | 60.0 Percentage of Participants |
Secondary
Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure.
Defined as amputation that was below the ankle, including digit amputation. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time frame: 30 days, 6 and 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 | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | 95.8 Percentage of participants |
| Lutonix DCB | Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | 88.6 Percentage of participants |
| Lutonix DCB | Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | 86.3 Percentage of participants |
| PTA Catheter | Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure. | 30-days Post Index Procedure | 95.5 Percentage of participants |
| PTA Catheter | Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure. | 6 months post index procedure | 88.2 Percentage of participants |
| PTA Catheter | Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure. | 12 months post index procedure | 83.1 Percentage of participants |
Secondary
Percentage of Procedures With Procedural Success at Time of Index Procedure.
A success is determined if there is restoration of at least 1 infrapopliteal artery with residual stenosis ≤ 30% (or ≤ 50% depending upon the version of the protocol) and inline outflow to the foot, irrespective of device success, and without a major adverse event during the index procedure.
Time frame: At time of Index Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lutonix DCB | Percentage of Procedures With Procedural Success at Time of Index Procedure. | 84.0 Percentage of Procedures |
| PTA Catheter | Percentage of Procedures With Procedural Success at Time of Index Procedure. | 81.4 Percentage of Procedures |