Peripheral Artery Disease
Conditions
Brief summary
The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.
Detailed description
The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries through 5 years.
Interventions
balloon angioplasty with a drug coated balloon
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure | 60 months Post Index Procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Acute Device Success at Time of Index Procedure | At time of Index Procedure | In certain procedures, more than one device was use resulting in a higher number of devices (894) than participants (657) for this endpoint. |
| Number of Participants With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure | 30 days post index procedure | This VIVA Safety Endpoint is defined as Freedom at 30 days from all-cause death, index limb amputation above the ankle and target vessel revascularization (TVR). |
| Number of Participants With Freedom From 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 (PPI) | 1, 6, 12, 24, 36, 48, and 60 months post index procedure | — |
| Number of Participants With Technical and Procedural Success | At time of index procedure | — |
| Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 | Composite of freedom from all-cause perioperative (≤ 30 day) death and freedom from the following at 1, 6, 12, 24, 36, 48, and 60 months: index limb amputation, index limb re-intervention, and index-limb-related death. |
| Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure | 6, 12, and 24 months post index procedure | Presented is a summary of the Mean change in resting Ankle Brachial Index (ABI) from baseline through 24 months post index procedure. The 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. A lower ABI number suggests more Peripheral Arterial Disease. |
| Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure | 1, 6, 12, and 24 months post index procedure | — |
| Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure | 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. |
| Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure | 6, 12, and 24 months post index procedure | * Alternative Primary and Secondary Patency based on alternative definitions of Duplex Ultrasonography (DUS) Peak Systolic Velocity Ratio (PSVR) \<2.0 and \<3.0 * Duplex Ultrasonography (DUS) Clinical Patency (DUS Peak Systolic Velocity Ratio (PSVR) \<2.5 without prior Clinically Driven TLR) |
| Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure | 6, 12, and 24 months post index procedure | Primary patency is defined as freedom from target lesion restenosis by core lab adjudication (DUS ≥ 2.5) and target lesion revascularization (TLR). |
Countries
Austria, Belgium, Germany, Switzerland, 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: balloon angioplasty with a drug coated balloon | 657 |
| Total | 657 |
Baseline characteristics
| Characteristic | Lutonix Drug Coated Balloon |
|---|---|
| Age, Continuous | 68.7 Years STANDARD_DEVIATION 9.5 |
| Baseline Rutherford Classification Rutherford 0 | 0 Participants |
| Baseline Rutherford Classification Rutherford 1 | 0 Participants |
| Baseline Rutherford Classification Rutherford 2 | 240 Participants |
| Baseline Rutherford Classification Rutherford 3 | 379 Participants |
| Baseline Rutherford Classification Rutherford 4 | 38 Participants |
| Baseline Rutherford Classification Rutherford 5 | 0 Participants |
| Baseline Rutherford Classification Rutherford 6 | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 645 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 657 participants |
| Sex: Female, Male Female | 238 Participants |
| Sex: Female, Male Male | 419 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 83 / 657 |
| other Total, other adverse events | 528 / 657 |
| serious Total, serious adverse events | 67 / 657 |
Outcome results
Primary
Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure
Time frame: 60 months Post Index Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lutonix Drug Coated Balloon | Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure | 0 Events |
Secondary
Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure
Presented is a summary of the Mean change in resting Ankle Brachial Index (ABI) from baseline through 24 months post index procedure. The 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. A lower ABI number suggests more Peripheral Arterial Disease.
Time frame: 6, 12, and 24 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lutonix Drug Coated Balloon | Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure | 6 months post index procedure | 0.19 Index | Standard Deviation 0.27 |
| Lutonix Drug Coated Balloon | Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure | At 24 months post index procedure | 0.16 Index | Standard Deviation 0.28 |
| Lutonix Drug Coated Balloon | Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure | 12 months post index procedure | 0.18 Index | Standard Deviation 0.27 |
Secondary
Improvement From Baseline in Rutherford Classification (Index Limb) at 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.
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 From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure | 6 months from baseline | Improved | 540 Participants |
| Lutonix Drug Coated Balloon | Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure | 6 months from baseline | Same | 49 Participants |
| Lutonix Drug Coated Balloon | Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure | 6 months from baseline | Worsened | 22 Participants |
| Lutonix Drug Coated Balloon | Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure | 12 months from baseline | Improved | 498 Participants |
| Lutonix Drug Coated Balloon | Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure | 12 months from baseline | Same | 62 Participants |
| Lutonix Drug Coated Balloon | Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure | 12 months from baseline | Worsened | 21 Participants |
| Lutonix Drug Coated Balloon | Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure | 24 months from baseline | Improved | 459 Participants |
| Lutonix Drug Coated Balloon | Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure | 24 months from baseline | Same | 57 Participants |
| Lutonix Drug Coated Balloon | Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure | 24 months from baseline | Worsened | 20 Participants |
Secondary
Number of Acute Device Success at Time of Index Procedure
In certain procedures, more than one device was use resulting in a higher number of devices (894) than participants (657) for this endpoint.
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 | 894 Devices |
Secondary
Number of Participants With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure
This VIVA Safety Endpoint is defined as Freedom at 30 days from all-cause death, index limb amputation above the ankle and target vessel revascularization (TVR).
Time frame: 30 days post index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure | 642 Participants |
Secondary
Number of Participants With Freedom From 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 (PPI)
Time frame: 1, 6, 12, 24, 36, 48, and 60 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Death : 6 months PPI | 4 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TVR : 60 months PPI | 192 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Reintervention Thrombosis1 month PPI | 0 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Reintervention Thrombosis : 6 months PPI | 0 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | ReinterventionThrombosis : 12 months PPI | 1 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Reintervention Thrombosis : 24 months PPI | 3 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | ReinterventionThrombosis : 36 months PPI | 4 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Reintervention Thrombosis : 48 months PPI | 4 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Cardiovascular Hospitalization : 48 months PPI | 60 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Cardiovascular Hospitalization : 60 months PPI | 60 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Vascular Complication : 1 month PPI | 12 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Death : 1 month PPI | 1 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Death : 12 months PPI | 8 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Death : 24 months PPI | 21 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Death : 36 months PPI | 45 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Death : 48 months PPI | 67 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Death : 60 months PPI | 83 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Amputation : 1 month PPI | 0 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Amputation : 6 months PPI | 0 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Amputation : 12 months PPI | 0 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Amputation : 24 months PPI | 1 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Amputation : 36 months PPI | 2 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Amputation : 48 months PPI | 4 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Amputation : 60 months PPI | 6 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Minor Amputation : 1 month PPI | 1 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Minor Amputation : 6 months PPI | 1 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Minor Amputation : 12 months PPI | 1 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Minor Amputation : 24 months PPI | 2 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Minor Amputation : 36 months PPI | 3 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Minor Amputation : 48 months PPI | 6 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Minor Amputation : 60 months PPI | 6 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Amputation Free Survival 1 month PPI | 646 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Amputation Free Survival : 6 months PPI | 632 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Amputation Free Survival : 12 months PPI | 618 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Amputation Free Survival : 24 months PPI | 580 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Amputation Free Survival : 36 months PPI | 547 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Amputation Free Survival : 48 months PPI | 515 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Amputation Free Survival : 60 months PPI | 487 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TLR : 1 month PPI | 3 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TLR : 6 months PPI | 21 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TLR : 12 months PPI | 78 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TLR : 24 months PPI | 133 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TLR : 36 months PPI | 154 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TLR : 48 months PPI | 168 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TLR : 60 months PPI | 174 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TVR : 1 month PPI | 4 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TVR : 6 months PPI | 26 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TVR : 12 months PPI | 83 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TVR : 24 months PPI | 144 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TVR : 36 months PPI | 167 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Total TVR : 48 months PPI | 184 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | ReinterventionThrombosis : 60 months PPI | 5 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Cardiovascular Hospitalization : 1 month PPI | 5 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Cardiovascular Hospitalization : 6 months PPI | 33 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Cardiovascular Hospitalization : 12 months PPI | 57 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Cardiovascular Hospitalization : 24 months PPI | 60 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Cardiovascular Hospitalization : 36 months PPI | 60 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Vascular Complication : 6 months PPI | 20 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Vascular Complication : 12 months PPI | 29 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Vascular Complication : 24 months PPI | 47 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Vascular Complication : 36 months PPI | 51 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Vascular Complication : 48 months PPI | 53 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From 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 (PPI) | Major Vascular Complication : 60 months PPI | 54 Participants |
Secondary
Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure
Time frame: 1, 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 Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure | 1 month post index procedure | 643 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure | 6 months post index procedure | 611 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure | 12 months post index procedure | 543 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure | 24 months post index proceedure | 456 Participants |
Secondary
Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure
* Alternative Primary and Secondary Patency based on alternative definitions of Duplex Ultrasonography (DUS) Peak Systolic Velocity Ratio (PSVR) \<2.0 and \<3.0 * Duplex Ultrasonography (DUS) Clinical Patency (DUS Peak Systolic Velocity Ratio (PSVR) \<2.5 without prior Clinically Driven TLR)
Time frame: 6, 12, and 24 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lutonix Drug Coated Balloon | Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure | DUS PSVR >= 3.0 : 24 months post index procdure | 213 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure | DUS PSVR >= 2.5 : 12 months post index procedure | 289 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure | DUS PSVR >= 2.5 : 24 months post index procdure | 203 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure | DUS PSVR >= 2.0 : 6 months post index procedure | 345 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure | DUS PSVR >= 2.0 : 12 months post index procedure | 242 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure | DUS PSVR >= 2.0 : 24 months post index procdure | 176 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure | DUS PSVR >= 3.0 : 6 months post index procedure | 411 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure | DUS PSVR >= 3.0 : 12 months post index procedure | 295 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure | DUS PSVR >= 2.5 : 6 months post index procedure | 396 Participants |
Secondary
Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure
Primary patency is defined as freedom from target lesion restenosis by core lab adjudication (DUS ≥ 2.5) and target lesion revascularization (TLR).
Time frame: 6, 12, and 24 months post index procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lutonix Drug Coated Balloon | Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure | 12 months post index procedure | 386 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure | 24 months post index procedure | 298 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure | 6 months post index procedure | 483 Participants |
Secondary
Number of Participants With Technical and Procedural Success
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 | 566 Participants |
| Lutonix Drug Coated Balloon | Number of Participants With Technical and Procedural Success | Procedural Success | 565 Participants |
Secondary
Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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
Composite of freedom from all-cause perioperative (≤ 30 day) death and freedom from the following at 1, 6, 12, 24, 36, 48, and 60 months: index limb amputation, index limb re-intervention, and index-limb-related death.
Time frame: 1, 6, 12, 24, 36, 48 and 60 months Post Index Procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lutonix Drug Coated Balloon | Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 | 36 Months Post Index Procedure | 385 Participants |
| Lutonix Drug Coated Balloon | Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 | 48 Months Post Index Procedure | 347 Participants |
| Lutonix Drug Coated Balloon | Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 Month Post Index Procedure | 638 Participants |
| Lutonix Drug Coated Balloon | Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 | 6 months post-index procedure | 596 Participants |
| Lutonix Drug Coated Balloon | Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 | 12 months post Index procedure | 525 Participants |
| Lutonix Drug Coated Balloon | Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 | 24 Months Post Index Procedure | 434 Participants |
| Lutonix Drug Coated Balloon | Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 | 60 Months Post Index Procedure | 320 Participants |