Artery Disease, Peripheral, Femoropopliteal Artery Occlusion, Peripheral Arterial Disease, Peripheral Vascular Disease
Conditions
Keywords
Percutaneous Transluminal Angioplasty, PTA, Peripheral Artery Disease, PAD, Paclitaxel
Brief summary
To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.
Detailed description
TRANSCEND is a prospective, multi-center, single-blind, randomized, controlled, noninferiority clinical trial. The trial will randomize approximately 446 subjects with symptomatic PAD due to stenoses of the femoral and/or popliteal arteries. Subjects meeting eligibility criteria will be randomized 1:1 to treatment with either the SurVeil DCB or the IN.PACT Admiral DCB, and followed for 60 months.
Interventions
DEVICESurmodics SurVeil DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
DEVICEMedtronic IN.PACT Admiral DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Sponsors
SurModics, Inc.
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
* Subject is ≥18 years. * Subject has target limb Rutherford classification 2, 3 or 4. * Subject has provided written informed consent and is willing to comply with study follow-up requirements. * De novo lesion(s) or non-stented restenotic lesion(s) occurring \>90 days after prior plain old balloon (POBA) angioplasty or \>180 days after prior DCB treatment. * Target lesion location starts ≥10 mm below the common femoral bifurcation and terminates distally at or above the end of the P1 segment of the popliteal artery. * Target vessel diameter ≥4 mm and ≤7 mm. * Target lesion must have angiographic evidence of ≥70% stenosis by operator visual estimate. * Chronic total occlusions may be included only after successful, uncomplicated wire crossing of target lesion via an anterograde approach and without the use of subintimal dissection techniques. * Target lesion must be ≤180 mm in length (one long lesion or multiple serial lesions) by operator visual estimate. Note: combination lesions must have a total lesion length of ≤180 mm by visual estimate and be separated by ≤30 mm. * Target lesion is located at least 30 mm from any stent, if target vessel was previously stented. * Successful, uncomplicated (without use of a crossing device) wire crossing of target lesion. Successful crossing of the target lesion occurs when the tip of the guide wire is distal to the target lesion without the occurrence of flow-limiting dissection or perforation and is judged by visual inspection to be within the true lumen. * After pre-dilatation, the target lesion is ≤70% residual stenosis, absence of a flow limiting dissection and treatable with available device matrix. * A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by angiography. * At least one patent native outflow artery to the ankle or foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography.
Exclusion criteria
* Subject has acute limb ischemia. * Subject underwent percutaneous transluminal angioplasty (PTA) of the target limb using plain old balloon angioplasty (POBA) or a stent within the previous 90 days. * Subject underwent any lower extremity percutaneous treatment using a paclitaxel-eluting stent or a DCB within the previous 90 days. * Subject underwent PTA of the target lesion using a DCB within the previous 180 days. * Subject has had prior vascular intervention in the contralateral limb within 14 days before the planned study index procedure or subject has planned vascular intervention in the contralateral limb within 30 days after the index procedure. * Subject is pregnant, breast-feeding or intends to become pregnant during the time of the study. * Subject has life expectancy less than 2 years. * Subject has a known allergy to contrast medium that cannot be adequately pre-medicated. * Subject is allergic to ALL antiplatelet treatments. * Subject has impaired renal function (i.e. serum creatinine level ≥2.5 mg/dL). * Subject is dialysis dependent. * Subject is receiving immunosuppressant therapy. * Subject has known or suspected active infection at the time of the index procedure. * Subject has platelet count \<100,000/mm3 or \>700,000/mm3. * Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the study procedure. * Subject is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT). * Subject has history of stroke within the past 90 days. * Subject has a history of myocardial infarction within the past 30 days. * Subject is unable to tolerate blood transfusions because of religious beliefs or other reasons. * Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol. * Subject is participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study, or subject is planning to participate in such studies prior to the completion of this study. * Subject has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure. * Subject had previous bypass surgery of the target lesion. * Subject had previous treatment of the target vessel with thrombolysis or surgery. * Subject is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol. * Target lesion has severe calcification (as defined by the PARC classification of calcification). * Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5 mm). * Target lesion requires treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices, or subintimal dissection techniques. * Significant target vessel tortuosity or other parameters prohibiting access to the target lesion. * Presence of thrombus in the target vessel. * Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤30% residual diameter stenosis without death or major complications. * Presence of an aortic, iliac or femoral artificial graft.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Lesion Patency Though 12 Months | 12 months | Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound \[DUS\] peak systolic velocity ratio \[PSVR\] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure. |
| Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR) | 12 months | Composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven TVR through 12 months post-index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Procedure Success | 72 hours | Defined as evidence of both acute technical success and absence of Peripheral Academic Research Consortium major adverse events (PARC MAEs; e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and or need for urgent/emergent vascular surgery) within 72 hours of the index procedure. |
| Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days | 30 days | Proportion of participation free of all-cause death, major target limb amputation and TVR through 30 days. All clinical endpoints adjudications by independent, blinded CEC. |
| Proportion of Participants With Primary Lesion Patency | 24 months | Primary patency through 24 months (only if both the primary safety and efficacy hypotheses of noninferiority are met). |
| Proportion of Participants With Target Vessel Patency | 12 months, 24 months | Defined as freedom from clinically-driven target vessel revascularization (TVR) and binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) within 12 and 24 months. |
| Proportion of Participants With Sustained Clinical Improvement | 6 months, 12 months, 24 months | Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months. |
| Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | 6 months, 12 months, 24 months | Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC. |
| Proportion of Participants With a Historical Major Adverse Events (MAEs) | 6 months, 12 months, 24 months | MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion, within 6, 12, 24 months. |
| Proportion of Participants With a Major Target Limb Amputation | 6 months, 12 months, 24 months | Major target limb amputation within 6, 12, 24 months as reported by site and adjudicated by CEC. |
| Proportion of Participants With Device Success | Day 0 | Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure, and achievement of \<50% residual stenosis of the target lesion (by core lab-assessed quantitative angiography \[QA\]) without flow-limiting arterial dissection (≥ 50% residual stenosis or dissection grade E or F) using only the study device. |
| Change in Target Limb Rutherford Class | Baseline, 1 month, 6 months, 12 months, and 24 months | Change in target limb Rutherford class from Baseline (BL) to 1, 6, 12, and 24 months. Rutherford classification criteria categorize the severity of chronic limb ischemia based on a clinical description of symptoms and pre-defined objective criteria. Possible scores range from 0 to 6 (with lower scores representing a better outcome) with scores defined as follows: 0 - Asymptomatic - no hemodynamically significant occlusive disease 1. \- Mild claudication 2. \- Moderate claudication 3. \- Severe claudication 4. \- Ischemic rest pain 5. \- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia 6. \- Major tissue loss, extending above transmetatarsal) with all scores defined as follows: Change = 1-Month scores - BL scores; 6-Month scores - BL scores; 12-Month scores - BL scores; 24-Month scores - BL scores |
| Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Screening, 1 month, 6 months, 12 months, and 24 months | Change in target limb PARC class from baseline to 1, 6, 12, and 24 months. PARC definitions of clinical symptom classification were used to classify subject claudication at baseline and subsequent follow-up visits. PARC clinical symptom classification is used to capture information regarding lower extremity symptoms and broadly define functional limitations of patients with lower extremity peripheral artery disease (PAD). Possible classifications (asymptomatic=best outcome to ischemic gangrene=worst outcome) include the following: Asymptomatic Mild claudication/limb symptoms (no limitation in walking) Moderate claudication/limb symptoms (able to walk without stopping \> 2 blocks or 200 meters or 4 minutes) Severe claudication/limb symptoms (only able to walk without stopping \< 2 blocks or 200 meters or 4 minutes) Ischemic rest pain (pain in the distal limb at rest, felt to be due to limited arterial perfusion) Ischemic ulcers on distal leg Ischemic gangrene Change = |
| Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | Screening, 6 months, 12 months, and 24 months | Decrease in target limb resting ABI or TBI ≥0.15 from baseline to 6, 12, and 24 months. Ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery. Toe brachial index (TBI) is the ratio of SBP measured at the toe to that measured at the brachial artery. if ABI could not be assessed, TBI could be used. |
| Change in Walking Impairment Questionnaire (WIQ) | Screening, 1 month, 12 months, and 24 months | Walking Impairment Questionnaire is a validated tool that has 4 domains (Walking Impairment, Walking Distance, Walking Speed, and Stair Climbing), each scored as a percent ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficulty with any of the tasks). A positive change in a score indicates an improvement. |
| Change in 6-Minute Walk Test (6MWT) | Screening, 12 months, and 24 months | Change in 6MWT from baseline to 12 and 24 months. |
| Change in Peripheral Artery Questionnaire (PAQ) | Screening, 1 month, 12 months, and 24 months | The PAQ consists of 7 domains including physical function, stability, symptom, treatment satisfaction, quality of life, social limitation, and summary. Scores range from 0 to 100, with a positive change indicating an improvement. Questionnaire responses include: Extremely Limited, Quite a bit Limited, Moderately Limited, Slightly Limited, Not at all Limited, Limited for other reasons or did not do the activity. |
| Proportion of Participants With a Thrombosis at the Target Lesion | 36 months, 48 months, 60 months | Thrombosis at target lesions within 36, 48, and 60 months as reported by the site and adjudicated by the CEC. |
| Proportion of Participants With a Thrombosis at the Target Lesion. | 6 months, 12 months, 24 months | Thrombosis at target lesion within 6, 12, 24 months as reported by the site and adjudicated by the CEC. |
| Proportion of Participants With Technical Success | Day 0 | Defined as achievement of a final residual diameter stenosis of \<50% (by core lab-assessed QA) without flow-limiting arterial dissection at the end of the procedure. |
Countries
Australia, Austria, Belgium, Czechia, Germany, Italy, Latvia, New Zealand, United States
Participant flow
Recruitment details
Subjects with symptomatic PAD presenting for percutaneous revascularization of stenosed femoral and/or popliteal arteries (either de novo lesions or non-stented restenotic lesions \>90 days from prior POBA angioplasty or \>180 days from prior DCB treatment) will be screened according to the protocol inclusion and exclusion criteria. Enrolled subjects who have met all the clinical inclusion criteria and none of the clinical exclusion criteria will then be screened for angiographic criteria.
Pre-assignment details
Subjects screened via angiographic assessment to confirm remaining study eligibility prior to randomization. Subjects not meeting criteria were considered screen failures and exited from the study.
Participants by arm
| Arm | Count |
|---|---|
| Surmodics SurVeil DCB Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.
Surmodics SurVeil DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter. | 222 |
| Medtronic IN.PACT Admiral DCB Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Medtronic IN.PACT Admiral DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter. | 224 |
| Total | 446 |
Baseline characteristics
| Characteristic | Medtronic IN.PACT Admiral DCB | Total | Surmodics SurVeil DCB |
|---|---|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 9.3 | 68.0 years STANDARD_DEVIATION 9.4 | 68.7 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 13 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 216 Participants | 428 Participants | 212 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 44 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) White | 199 Participants | 390 Participants | 191 Participants |
| Sex: Female, Male Female | 82 Participants | 165 Participants | 83 Participants |
| Sex: Female, Male Male | 142 Participants | 281 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 41 / 222 | 37 / 224 |
| other Total, other adverse events | 159 / 222 | 170 / 224 |
| serious Total, serious adverse events | 166 / 222 | 162 / 224 |
Outcome results
Primary
Primary Lesion Patency Though 12 Months
Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound \[DUS\] peak systolic velocity ratio \[PSVR\] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.
Time frame: 12 months
Population: The primary analysis of the primary effectiveness endpoint was carried out on all randomized participants. For participants missing primary effectiveness endpoint status (48 for SurVeil DCB and 31 for IN.PACT Admiral DCB), a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SurVeil DCB | Primary Lesion Patency Though 12 Months | 82.2 percentage of participants |
| IN.PACT Admiral DCB | Primary Lesion Patency Though 12 Months | 85.9 percentage of participants |
Comparison: The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to efficacy endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.p-value: 0.0029Farrington-Manning test
Primary
Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)
Composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven TVR through 12 months post-index procedure.
Time frame: 12 months
Population: Multiple Imputation was carried out on Intention-to-Treat (ITT) subjects. For subjects missing primary safety endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SurVeil DCB | Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR) | 91.8 percentage of participants |
| IN.PACT Admiral DCB | Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR) | 89.8 percentage of participants |
Comparison: The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to safety endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.p-value: <0.0001Farrington-Manning test
Secondary
Change in 6-Minute Walk Test (6MWT)
Change in 6MWT from baseline to 12 and 24 months.
Time frame: Screening, 12 months, and 24 months
Population: Intention-to-Treat population for whom the 6-Minute Walk Test information from Baseline to each respective time point was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SurVeil DCB | Change in 6-Minute Walk Test (6MWT) | Change from BL to 12-Months | 45.8 Distance walked (meters) | Standard Deviation 118.8 |
| SurVeil DCB | Change in 6-Minute Walk Test (6MWT) | Change from BL to 24-Months | 25.7 Distance walked (meters) | Standard Deviation 98.8 |
| IN.PACT Admiral DCB | Change in 6-Minute Walk Test (6MWT) | Change from BL to 12-Months | 60.7 Distance walked (meters) | Standard Deviation 113.6 |
| IN.PACT Admiral DCB | Change in 6-Minute Walk Test (6MWT) | Change from BL to 24-Months | 52.5 Distance walked (meters) | Standard Deviation 122.4 |
p-value: 0.237t-test, 2 sided
p-value: 0.04t-test, 2 sided
Secondary
Change in Peripheral Artery Questionnaire (PAQ)
The PAQ consists of 7 domains including physical function, stability, symptom, treatment satisfaction, quality of life, social limitation, and summary. Scores range from 0 to 100, with a positive change indicating an improvement. Questionnaire responses include: Extremely Limited, Quite a bit Limited, Moderately Limited, Slightly Limited, Not at all Limited, Limited for other reasons or did not do the activity.
Time frame: Screening, 1 month, 12 months, and 24 months
Population: Intention-to-Treat Analysis Population for whom the PAQ score information from baseline to each respective time point was available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Month: Stability Score | 0.0 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Stability Score | 50.0 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Symptom Score | 33.3 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Treatment Satisfaction Score | 0.0 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Quality of Life Score | 41.7 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Social Limitation Score | 25.0 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Summary Score | 32.6 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Physical Function Score | 25.0 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Stability Score | 0.0 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Symptom Score | 27.8 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Treatment Satisfaction Score | 0.0 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Quality of Life Score | 33.3 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Social Limitation Score | 25.0 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Summary Score | 29.7 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Months: Physical Function Score | 25.0 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Months: Symptom Score | 27.8 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Physical Function Score | 25.0 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Months: Treatment Satisfaction Score | 0.0 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Months: Quality of Life Score | 41.7 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Months: Social Limitation Score | 25.0 score on a scale |
| SurVeil DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Months: Summary Score | 29.9 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Treatment Satisfaction Score | 0.0 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Physical Function Score | 29.2 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Month: Stability Score | 0.0 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Stability Score | 50.0 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Quality of Life Score | 33.3 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Symptom Score | 30.6 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Months: Symptom Score | 33.3 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Treatment Satisfaction Score | 0.0 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Social Limitation Score | 25.0 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Quality of Life Score | 33.3 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Months: Summary Score | 28.5 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Social Limitation Score | 25.0 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Summary Score | 30.3 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 1-Month: Summary Score | 30.2 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Months: Treatment Satisfaction Score | 0.0 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Physical Function Score | 25.0 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Months: Physical Function Score | 29.2 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Stability Score | 0.0 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Months: Social Limitation Score | 25.0 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 12-Months: Symptom Score | 30.6 score on a scale |
| IN.PACT Admiral DCB | Change in Peripheral Artery Questionnaire (PAQ) | 24-Months: Quality of Life Score | 33.3 score on a scale |
p-value: 0.772Wilcoxon (Mann-Whitney)
p-value: 0.93Wilcoxon (Mann-Whitney)
p-value: 0.546Wilcoxon (Mann-Whitney)
p-value: 0.621Wilcoxon (Mann-Whitney)
p-value: 0.133Wilcoxon (Mann-Whitney)
p-value: 0.592Wilcoxon (Mann-Whitney)
p-value: 0.601Wilcoxon (Mann-Whitney)
p-value: 0.185Wilcoxon (Mann-Whitney)
p-value: 0.856Wilcoxon (Mann-Whitney)
p-value: 0.541Wilcoxon (Mann-Whitney)
p-value: 0.731Wilcoxon (Mann-Whitney)
p-value: 0.696Wilcoxon (Mann-Whitney)
p-value: 0.716Wilcoxon (Mann-Whitney)
p-value: 0.797Wilcoxon (Mann-Whitney)
p-value: 0.29Wilcoxon (Mann-Whitney)
p-value: 0.473Wilcoxon (Mann-Whitney)
p-value: 0.278Wilcoxon (Mann-Whitney)
p-value: 0.974Wilcoxon (Mann-Whitney)
p-value: 0.266Wilcoxon (Mann-Whitney)
p-value: 0.656Wilcoxon (Mann-Whitney)
p-value: 0.959Wilcoxon (Mann-Whitney)
Secondary
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class
Change in target limb PARC class from baseline to 1, 6, 12, and 24 months. PARC definitions of clinical symptom classification were used to classify subject claudication at baseline and subsequent follow-up visits. PARC clinical symptom classification is used to capture information regarding lower extremity symptoms and broadly define functional limitations of patients with lower extremity peripheral artery disease (PAD). Possible classifications (asymptomatic=best outcome to ischemic gangrene=worst outcome) include the following: Asymptomatic Mild claudication/limb symptoms (no limitation in walking) Moderate claudication/limb symptoms (able to walk without stopping \> 2 blocks or 200 meters or 4 minutes) Severe claudication/limb symptoms (only able to walk without stopping \< 2 blocks or 200 meters or 4 minutes) Ischemic rest pain (pain in the distal limb at rest, felt to be due to limited arterial perfusion) Ischemic ulcers on distal leg Ischemic gangrene Change =
Time frame: Screening, 1 month, 6 months, 12 months, and 24 months
Population: Analysis of the secondary endpoint includes the Intention-to-Treat analysis population for whom PARC clinical classification was available at the respective timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade ≥+3 Markedly improved | 80 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade -1 Mildly worsening | 2 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade +2 Moderately improved | 53 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade +2 Moderately improved | 65 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade +1 Mildly improved | 27 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade +2 Moderately improved | 59 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade 0 No change | 17 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade +1 Mildly improved | 16 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade -1 Mildly worsening | 6 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade -2 Moderately worsening | 0 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade -2 Moderately worsening | 0 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade 0 No change | 12 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade ≤-3 Markedly worsening | 0 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade 0 No change | 18 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade ≥+3 Markedly improved | 73 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade -1 Mildly worsening | 1 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade +2 Moderately improved | 37 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade ≤-3 Markedly worsening | 1 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade +1 Mildly improved | 25 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade -2 Moderately worsening | 1 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade 0 No change | 19 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade +1 Mildly improved | 31 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade -1 Mildly worsening | 2 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade ≤-3 Markedly worsening | 1 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade -2 Moderately worsening | 0 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade ≥+3 Markedly improved | 99 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade ≤-3 Markedly worsening | 0 Participants |
| SurVeil DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade ≥+3 Markedly improved | 99 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade ≤-3 Markedly worsening | 0 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade ≥+3 Markedly improved | 89 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade +2 Moderately improved | 78 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade +1 Mildly improved | 31 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade 0 No change | 18 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade -1 Mildly worsening | 4 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade -2 Moderately worsening | 0 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC class from BL to 1-Month: Grade ≤-3 Markedly worsening | 1 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade ≥+3 Markedly improved | 92 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade +2 Moderately improved | 70 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade +1 Mildly improved | 30 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade 0 No change | 14 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade -1 Mildly worsening | 2 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade -2 Moderately worsening | 0 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 6-Months: Grade ≤-3 Markedly worsening | 0 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade ≥+3 Markedly improved | 69 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade +2 Moderately improved | 80 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade +1 Mildly improved | 31 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade 0 No change | 17 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade -1 Mildly worsening | 4 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade -2 Moderately worsening | 1 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Class from BL to 12-Months: Grade ≤-3 Markedly worsening | 1 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade ≥+3 Markedly improved | 63 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade +2 Moderately improved | 62 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade +1 Mildly improved | 33 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade 0 No change | 14 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade -1 Mildly worsening | 5 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Peripheral Academic Research Consortium (PARC) Class | Change in PARC Classification from BL to 24-Months: Grade -2 Moderately worsening | 1 Participants |
p-value: 0.32Wilcoxon (Mann-Whitney)
p-value: 0.132Wilcoxon (Mann-Whitney)
p-value: 0.248Wilcoxon (Mann-Whitney)
p-value: 0.194Wilcoxon (Mann-Whitney)
Secondary
Change in Target Limb Rutherford Class
Change in target limb Rutherford class from Baseline (BL) to 1, 6, 12, and 24 months. Rutherford classification criteria categorize the severity of chronic limb ischemia based on a clinical description of symptoms and pre-defined objective criteria. Possible scores range from 0 to 6 (with lower scores representing a better outcome) with scores defined as follows: 0 - Asymptomatic - no hemodynamically significant occlusive disease 1. \- Mild claudication 2. \- Moderate claudication 3. \- Severe claudication 4. \- Ischemic rest pain 5. \- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia 6. \- Major tissue loss, extending above transmetatarsal) with all scores defined as follows: Change = 1-Month scores - BL scores; 6-Month scores - BL scores; 12-Month scores - BL scores; 24-Month scores - BL scores
Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months
Population: Analysis of the secondary endpoint includes the Intention-to-Treat analysis population for whom Rutherford classification was available at the respective timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | No change | 18 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | Grade ≥+3 Markedly improved | 101 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | Grade -1 Mildly worsening | 5 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | Grade -1 Mildly worsening | 1 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | Grade -2 Moderately worsening | 0 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | Grade -1 Mildly worsening | 1 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | Grade ≤-3 Markedly worsening | 0 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | Grade -2 Moderately worsening | 1 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | Grade ≥+3 Markedly improved | 77 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | Grade +2 Moderately improved | 65 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | Grade +2 Moderately improved | 36 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | Grade ≤-3 Markedly worsening | 1 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | Grade +1 Mildly improved | 26 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | Grade ≤-3 Markedly worsening | 1 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | No change | 17 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | Grade ≥+3 Markedly improved | 82 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | Grade -1 Mildly worsening | 1 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | Grade +1 Mildly improved | 15 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | Grade -2 Moderately worsening | 0 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | Grade +2 Moderately improved | 50 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | Grade ≤-3 Markedly worsening | 0 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | Grade -2 Moderately worsening | 0 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | Grade ≥+3 Markedly improved | 101 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | Grade +1 Mildly improved | 28 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | Grade +2 Moderately improved | 63 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | No change | 11 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | Grade +1 Mildly improved | 28 Participants |
| SurVeil DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | No change | 16 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | Grade +1 Mildly improved | 29 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | No change | 20 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | Grade -1 Mildly worsening | 2 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | Grade -2 Moderately worsening | 0 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | Grade ≤-3 Markedly worsening | 1 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | Grade ≥+3 Markedly improved | 95 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | Grade +2 Moderately improved | 70 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | Grade +1 Mildly improved | 30 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | No change | 12 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | Grade -1 Mildly worsening | 2 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | Grade -2 Moderately worsening | 0 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 6-Months | Grade ≤-3 Markedly worsening | 0 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | Grade ≥+3 Markedly improved | 74 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | Grade +2 Moderately improved | 76 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | Grade +1 Mildly improved | 33 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | No change | 16 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | Grade -1 Mildly worsening | 3 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | Grade -2 Moderately worsening | 2 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 12-Months | Grade ≤-3 Markedly worsening | 0 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | Grade ≥+3 Markedly improved | 65 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | Grade +2 Moderately improved | 60 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | Grade +1 Mildly improved | 34 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | No change | 14 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | Grade -1 Mildly worsening | 4 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | Grade -2 Moderately worsening | 1 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 24-Months | Grade ≤-3 Markedly worsening | 0 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | Grade ≥+3 Markedly improved | 90 Participants |
| IN.PACT Admiral DCB | Change in Target Limb Rutherford Class | Change in Rutherford Classification from Baseline to 1-Month | Grade +2 Moderately improved | 78 Participants |
p-value: 0.193Wilcoxon (Mann-Whitney)
p-value: 0.14Wilcoxon (Mann-Whitney)
p-value: 0.372Wilcoxon (Mann-Whitney)
p-value: 0.104Wilcoxon (Mann-Whitney)
Secondary
Change in Walking Impairment Questionnaire (WIQ)
Walking Impairment Questionnaire is a validated tool that has 4 domains (Walking Impairment, Walking Distance, Walking Speed, and Stair Climbing), each scored as a percent ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficulty with any of the tasks). A positive change in a score indicates an improvement.
Time frame: Screening, 1 month, 12 months, and 24 months
Population: Intention-to-Treat population for whom Walking Impairment Questionnaire information was available from Baseline to each respective time point.~An increase in a WIQ score signifies improvement.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SurVeil DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 1-Month: Walking Impairment Score | 50.0 score on a scale |
| SurVeil DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 1-Month: Walking Distance Score | 37.6 score on a scale |
| SurVeil DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 1-Month: Walking Speed Score | 15.2 score on a scale |
| SurVeil DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 1-Month: Stair Climbing Score | 20.8 score on a scale |
| SurVeil DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 12-Months: Walking Impairment Score | 25.0 score on a scale |
| SurVeil DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 12-Months: Walking Distance Score | 26.3 score on a scale |
| SurVeil DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 12-Months: Walking Speed Score | 17.4 score on a scale |
| SurVeil DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 12-Months: Stair Climbing Score | 20.8 score on a scale |
| SurVeil DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 24-Months: Walking Impairment Score | 50.0 score on a scale |
| SurVeil DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 24-Months: Walking Distance Score | 26.8 score on a scale |
| SurVeil DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 24-Months: Walking Speed Score | 10.9 score on a scale |
| SurVeil DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 24-Months: Stair Climbing Score | 20.8 score on a scale |
| IN.PACT Admiral DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 24-Months: Walking Speed Score | 12.0 score on a scale |
| IN.PACT Admiral DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 1-Month: Walking Impairment Score | 50.0 score on a scale |
| IN.PACT Admiral DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 12-Months: Walking Speed Score | 17.4 score on a scale |
| IN.PACT Admiral DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 1-Month: Walking Distance Score | 23.4 score on a scale |
| IN.PACT Admiral DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 24-Months: Walking Distance Score | 27.6 score on a scale |
| IN.PACT Admiral DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 1-Month: Walking Speed Score | 15.2 score on a scale |
| IN.PACT Admiral DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 12-Months: Stair Climbing Score | 20.8 score on a scale |
| IN.PACT Admiral DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 1-Month: Stair Climbing Score | 12.5 score on a scale |
| IN.PACT Admiral DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 24-Months: Stair Climbing Score | 16.7 score on a scale |
| IN.PACT Admiral DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 12-Months: Walking Impairment Score | 50.0 score on a scale |
| IN.PACT Admiral DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 24-Months: Walking Impairment Score | 50.0 score on a scale |
| IN.PACT Admiral DCB | Change in Walking Impairment Questionnaire (WIQ) | Change from BL to 12-Months: Walking Distance Score | 27.7 score on a scale |
p-value: 0.995Wilcoxon (Mann-Whitney)
p-value: 0.158Wilcoxon (Mann-Whitney)
p-value: 0.695Wilcoxon (Mann-Whitney)
p-value: 0.086Wilcoxon (Mann-Whitney)
p-value: 0.331Wilcoxon (Mann-Whitney)
p-value: 0.58Wilcoxon (Mann-Whitney)
p-value: 0.563Wilcoxon (Mann-Whitney)
p-value: 0.27Wilcoxon (Mann-Whitney)
p-value: 0.869Wilcoxon (Mann-Whitney)
p-value: 0.837Wilcoxon (Mann-Whitney)
p-value: 0.674Wilcoxon (Mann-Whitney)
p-value: 0.563Wilcoxon (Mann-Whitney)
Secondary
Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)
Decrease in target limb resting ABI or TBI ≥0.15 from baseline to 6, 12, and 24 months. Ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery. Toe brachial index (TBI) is the ratio of SBP measured at the toe to that measured at the brachial artery. if ABI could not be assessed, TBI could be used.
Time frame: Screening, 6 months, 12 months, and 24 months
Population: Analysis of the secondary endpoint includes the Intention-to-Treat analysis population for whom the ABI or TBI was available at the respective timepoint. Worsening of ABI was defined as a decrease in ABI ≥0.15 from baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil DCB | Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | BL to 6-Months: Decrease in Resting Target Limb ABI ≥0.15 | 6 Participants |
| SurVeil DCB | Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | BL to 6-Months: Decrease in Resting Target Limb TBI ≥0.15 | 0 Participants |
| SurVeil DCB | Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | BL to 12-Months: Decrease in Resting Target Limb ABI ≥0.15 | 15 Participants |
| SurVeil DCB | Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | BL to 12-Months: Decrease in Resting Target Limb TBI ≥0.15 | 2 Participants |
| SurVeil DCB | Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | BL to 24-Months: Decrease in Resting Target Limb ABI ≥0.15 | 9 Participants |
| SurVeil DCB | Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | BL to 24-Months: Decrease in Resting Target Limb TBI ≥0.15 | 1 Participants |
| IN.PACT Admiral DCB | Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | BL to 24-Months: Decrease in Resting Target Limb ABI ≥0.15 | 15 Participants |
| IN.PACT Admiral DCB | Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | BL to 6-Months: Decrease in Resting Target Limb ABI ≥0.15 | 8 Participants |
| IN.PACT Admiral DCB | Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | BL to 12-Months: Decrease in Resting Target Limb TBI ≥0.15 | 1 Participants |
| IN.PACT Admiral DCB | Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | BL to 6-Months: Decrease in Resting Target Limb TBI ≥0.15 | 0 Participants |
| IN.PACT Admiral DCB | Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | BL to 24-Months: Decrease in Resting Target Limb TBI ≥0.15 | 1 Participants |
| IN.PACT Admiral DCB | Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) | BL to 12-Months: Decrease in Resting Target Limb ABI ≥0.15 | 6 Participants |
p-value: 0.789Fisher Exact
p-value: 1Fisher Exact
p-value: 0.041Fisher Exact
p-value: 1Fisher Exact
p-value: 0.401Fisher Exact
p-value: 1Fisher Exact
Secondary
Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days
Proportion of participation free of all-cause death, major target limb amputation and TVR through 30 days. All clinical endpoints adjudications by independent, blinded CEC.
Time frame: 30 days
Population: Intent-to-Treat Analysis Population with assessments/follow-up completed through 30 days and/or subjects who experienced the endpoint (or any of its components) were included in the analysis (i.e., counted in the denominator).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SurVeil DCB | Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days | 217 Participants |
| IN.PACT Admiral DCB | Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days | 223 Participants |
p-value: 0.494Fisher Exact
Secondary
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)
Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.
Time frame: 6 months, 12 months, 24 months
Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 30 days for 1-month time point, 180 days for 6-month time point, 365 days for 12-month time point, 730 days for 24-month time point) or who have adequate follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil DCB | Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | Clinically-driven TLR at 6-Months | 3 Participants |
| SurVeil DCB | Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | Clinically-driven TLR at 12-Months | 11 Participants |
| SurVeil DCB | Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | Clinically-driven TLR at 24-Months | 27 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | Clinically-driven TLR at 6-Months | 3 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | Clinically-driven TLR at 12-Months | 10 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | Clinically-driven TLR at 24-Months | 24 Participants |
p-value: 1Fisher Exact
p-value: 0.823Fisher Exact
p-value: 0.454Fisher Exact
Secondary
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)
Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.
Time frame: 36 months, 48 months, 60 months
Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 1095 days for 36-month time point, 1460 days for 48-month time point,1825 days for 60-month time point) or who have adequate follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil DCB | Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | Clinically-driven TLR at 36-Months | 36 Participants |
| SurVeil DCB | Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | Clinically-driven TLR at 486-Months | 42 Participants |
| SurVeil DCB | Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | Clinically-driven TLR at 60-Months | 44 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | Clinically-driven TLR at 36-Months | 39 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | Clinically-driven TLR at 486-Months | 48 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR) | Clinically-driven TLR at 60-Months | 50 Participants |
p-value: 1Fisher Exact
p-value: 0.903Fisher Exact
p-value: 1Fisher Exact
Secondary
Proportion of Participants With a Historical Major Adverse Events (MAEs)
MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion, within 6, 12, 24 months.
Time frame: 6 months, 12 months, 24 months
Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 30 days for 1-month time point, 180 days for 6-month time point, 365 days for 12-month time point, 730 days for 24-month time point) or who have adequate follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil DCB | Proportion of Participants With a Historical Major Adverse Events (MAEs) | Historical MAEs at 6-Months | 6 Participants |
| SurVeil DCB | Proportion of Participants With a Historical Major Adverse Events (MAEs) | Historical MAEs at 12-Months | 17 Participants |
| SurVeil DCB | Proportion of Participants With a Historical Major Adverse Events (MAEs) | Historical MAEs at 24-Months | 43 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Historical Major Adverse Events (MAEs) | Historical MAEs at 6-Months | 4 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Historical Major Adverse Events (MAEs) | Historical MAEs at 12-Months | 17 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Historical Major Adverse Events (MAEs) | Historical MAEs at 24-Months | 39 Participants |
p-value: 0.535Fisher Exact
p-value: 0.86Fisher Exact
p-value: 0.39Fisher Exact
Secondary
Proportion of Participants With a Historical Major Adverse Events (MAEs)
MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion within 36, 48, and 60 months.
Time frame: 36 months, 48 months, 60 months
Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 1095 days for 36-month time point, 1460 days for 48--month time point, 1825 days for 60-month time point) or who have adequate follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil DCB | Proportion of Participants With a Historical Major Adverse Events (MAEs) | Historical MAEs at 36-Months | 56 Participants |
| SurVeil DCB | Proportion of Participants With a Historical Major Adverse Events (MAEs) | Historical MAEs at 48-Months | 69 Participants |
| SurVeil DCB | Proportion of Participants With a Historical Major Adverse Events (MAEs) | Historical MAEs at 60-Months | 79 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Historical Major Adverse Events (MAEs) | Historical MAEs at 36-Months | 62 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Historical Major Adverse Events (MAEs) | Historical MAEs at 48-Months | 75 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Historical Major Adverse Events (MAEs) | Historical MAEs at 60-Months | 83 Participants |
p-value: 0.913Fisher Exact
p-value: 1Fisher Exact
p-value: 0.839Fisher Exact
Secondary
Proportion of Participants With a Major Target Limb Amputation
Major target limb amputation within 6, 12, 24 months as reported by site and adjudicated by CEC.
Time frame: 6 months, 12 months, 24 months
Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 30 days for 1-month time point, 180 days for 6-month time point, 365 days for 12-month time point, 730 days for 24-month time point) or who have adequate follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil DCB | Proportion of Participants With a Major Target Limb Amputation | Major Target Limb Amputation at 6-Months | 0 Participants |
| SurVeil DCB | Proportion of Participants With a Major Target Limb Amputation | Major Target Limb Amputation at 12-Months | 0 Participants |
| SurVeil DCB | Proportion of Participants With a Major Target Limb Amputation | Major Target Limb Amputation at 24-Months | 0 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Major Target Limb Amputation | Major Target Limb Amputation at 6-Months | 0 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Major Target Limb Amputation | Major Target Limb Amputation at 12-Months | 0 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Major Target Limb Amputation | Major Target Limb Amputation at 24-Months | 1 Participants |
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
Secondary
Proportion of Participants With a Major Target Limb Amputation
Major target limb amputation within 36, 48, and 60 months as reported by site and adjudicated by CEC.
Time frame: 36 months, 48 months, 60 months
Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 1095 days for 36-month time point, 1460 days for 48--month time point, 1825 days for 60-month time point) or who have adequate follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil DCB | Proportion of Participants With a Major Target Limb Amputation | Major Target Limb Amputation at 36-Months | 0 Participants |
| SurVeil DCB | Proportion of Participants With a Major Target Limb Amputation | Major Target Limb Amputation at 48-Months | 0 Participants |
| SurVeil DCB | Proportion of Participants With a Major Target Limb Amputation | Major Target Limb Amputation at 60-Months | 0 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Major Target Limb Amputation | Major Target Limb Amputation at 36-Months | 1 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Major Target Limb Amputation | Major Target Limb Amputation at 48-Months | 2 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Major Target Limb Amputation | Major Target Limb Amputation at 60-Months | 3 Participants |
p-value: 1Fisher Exact
p-value: 0.5Fisher Exact
p-value: 0.251Fisher Exact
Secondary
Proportion of Participants With a Thrombosis at the Target Lesion
Thrombosis at target lesions within 36, 48, and 60 months as reported by the site and adjudicated by the CEC.
Time frame: 36 months, 48 months, 60 months
Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 1095 days for 36-month time point, 1460 days for 48--month time point, 1825 days for 60-month time point) or who have adequate follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil DCB | Proportion of Participants With a Thrombosis at the Target Lesion | Thrombosis at Target Lesion at 36-Months | 1 Participants |
| SurVeil DCB | Proportion of Participants With a Thrombosis at the Target Lesion | Thrombosis at Target Lesion at 48-Months | 2 Participants |
| SurVeil DCB | Proportion of Participants With a Thrombosis at the Target Lesion | Thrombosis at Target Lesion at 60-Months | 3 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Thrombosis at the Target Lesion | Thrombosis at Target Lesion at 36-Months | 0 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Thrombosis at the Target Lesion | Thrombosis at Target Lesion at 48-Months | 1 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Thrombosis at the Target Lesion | Thrombosis at Target Lesion at 60-Months | 1 Participants |
p-value: 0.478Fisher Exact
p-value: 0.605Fisher Exact
p-value: 0.345Fisher Exact
Secondary
Proportion of Participants With a Thrombosis at the Target Lesion.
Thrombosis at target lesion within 6, 12, 24 months as reported by the site and adjudicated by the CEC.
Time frame: 6 months, 12 months, 24 months
Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 30 days for 1-month time point, 180 days for 6-month time point, 365 days for 12-month time point, 760 days for 24-month time point) or who have adequate follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil DCB | Proportion of Participants With a Thrombosis at the Target Lesion. | Thrombosis at Target Lesion at 6-Months | 0 Participants |
| SurVeil DCB | Proportion of Participants With a Thrombosis at the Target Lesion. | Thrombosis at Target Lesion at 12-Months | 0 Participants |
| SurVeil DCB | Proportion of Participants With a Thrombosis at the Target Lesion. | Thrombosis at Target Lesion at 24-Months | 1 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Thrombosis at the Target Lesion. | Thrombosis at Target Lesion at 24-Months | 0 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Thrombosis at the Target Lesion. | Thrombosis at Target Lesion at 6-Months | 0 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With a Thrombosis at the Target Lesion. | Thrombosis at Target Lesion at 12-Months | 0 Participants |
p-value: 1Fisher Exact
p-value: 0.472Fisher Exact
Secondary
Proportion of Participants With Device Success
Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure, and achievement of \<50% residual stenosis of the target lesion (by core lab-assessed quantitative angiography \[QA\]) without flow-limiting arterial dissection (≥ 50% residual stenosis or dissection grade E or F) using only the study device.
Time frame: Day 0
Population: Intention-to-Treat (ITT) Analysis Population with quantitative angiography completed by an angiography core lab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SurVeil DCB | Proportion of Participants With Device Success | 199 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With Device Success | 208 Participants |
Comparison: The incidence estimates will be reported along with a p-value from a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.p-value: 0.579Fisher Exact
Secondary
Proportion of Participants With Primary Lesion Patency
Primary patency through 24 months (only if both the primary safety and efficacy hypotheses of noninferiority are met).
Time frame: 24 months
Population: The analysis was carried out on ITT subjects with available data (i.e., subjects who experienced CD-TLR through 790 days and/or binary restenosis through 24 months, or had at least 670 days of follow-up).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SurVeil DCB | Proportion of Participants With Primary Lesion Patency | 100 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With Primary Lesion Patency | 121 Participants |
Comparison: The objective is to assess whether the primary patency rate of subjects in the SurVeil DCB group is noninferior to that of the IN.PACT Admiral DCB group:p-value: 0.0059Farrington-Manning test
Secondary
Proportion of Participants With Procedure Success
Defined as evidence of both acute technical success and absence of Peripheral Academic Research Consortium major adverse events (PARC MAEs; e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and or need for urgent/emergent vascular surgery) within 72 hours of the index procedure.
Time frame: 72 hours
Population: Intention-to-Treat (ITT) Analysis Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SurVeil DCB | Proportion of Participants With Procedure Success | 217 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With Procedure Success | 222 Participants |
Comparison: The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.p-value: 1Fisher Exact
Secondary
Proportion of Participants With Sustained Clinical Improvement
Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months.
Time frame: 6 months, 12 months, 24 months
Population: Intent-to-Treat analysis population consisting of participants either experiencing the event within the period or who have adequate follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil DCB | Proportion of Participants With Sustained Clinical Improvement | 6-Months | 158 Participants |
| SurVeil DCB | Proportion of Participants With Sustained Clinical Improvement | 12-Months | 121 Participants |
| SurVeil DCB | Proportion of Participants With Sustained Clinical Improvement | 24-Months | 93 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With Sustained Clinical Improvement | 6-Months | 172 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With Sustained Clinical Improvement | 12-Months | 142 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With Sustained Clinical Improvement | 24-Months | 111 Participants |
p-value: 0.699Fisher Exact
p-value: 0.447Fisher Exact
p-value: 0.589Fisher Exact
Secondary
Proportion of Participants With Target Vessel Patency
Defined as freedom from clinically-driven target vessel revascularization (TVR) and binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) within 12 and 24 months.
Time frame: 12 months, 24 months
Population: Intention-to-Treat (ITT) analysis population with available data (i.e., subjects who experienced CD-TLR through 790 days and/or binary restenosis through 24 months, or had at least 670 days of follow-up).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil DCB | Proportion of Participants With Target Vessel Patency | Target Vessel Patency at 12-Months | 143 Participants |
| SurVeil DCB | Proportion of Participants With Target Vessel Patency | Target Vessel Patency at 24-Months | 102 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With Target Vessel Patency | Target Vessel Patency at 12-Months | 165 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With Target Vessel Patency | Target Vessel Patency at 24-Months | 118 Participants |
Comparison: The main analysis of the secondary endpoints will be carried out using the ITT analysis set.p-value: 0.699Fisher Exact
Comparison: The main analysis of the secondary endpoints will be carried out using the ITT analysis set.p-value: 1Fisher Exact
Secondary
Proportion of Participants With Technical Success
Defined as achievement of a final residual diameter stenosis of \<50% (by core lab-assessed QA) without flow-limiting arterial dissection at the end of the procedure.
Time frame: Day 0
Population: Intention-to-Treat (ITT) Analysis Population with quantitative angiography completed by an angiography core lab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SurVeil DCB | Proportion of Participants With Technical Success | 217 Participants |
| IN.PACT Admiral DCB | Proportion of Participants With Technical Success | 223 Participants |
Comparison: The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.p-value: 1Fisher Exact