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.

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.

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.

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.

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.

Intention-to-Treat (ITT) Analysis Population with quantitative angiography completed by an angiography core lab.

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.

Intention-to-Treat (ITT) Analysis Population with quantitative angiography completed by an angiography core lab.

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.

Intention-to-Treat (ITT) Analysis Population

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.

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).

Primary patency through 24 months (only if both the primary safety and efficacy hypotheses of noninferiority are met).

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).

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.

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).

Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months.

Intent-to-Treat analysis population consisting of participants either experiencing the event within the period or who have adequate follow-up.

Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.

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.

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.

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.

Major target limb amputation within 6, 12, 24 months as reported by site and adjudicated by CEC.

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.

Thrombosis at target lesion within 6, 12, 24 months as reported by the site and adjudicated by the CEC.

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.

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

Analysis of the secondary endpoint includes the Intention-to-Treat analysis population for whom Rutherford classification was available at the respective timepoint.

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 =

Analysis of the secondary endpoint includes the Intention-to-Treat analysis population for whom PARC clinical classification was available at the respective timepoint.

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.

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.

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.

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.

Change in 6MWT from baseline to 12 and 24 months.

Intention-to-Treat population for whom the 6-Minute Walk Test information from Baseline to each respective time point was available.

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.

Intention-to-Treat Analysis Population for whom the PAQ score information from baseline to each respective time point was available.

Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.

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.

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.

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.

Major target limb amputation within 36, 48, and 60 months as reported by site and adjudicated by CEC.

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.

Thrombosis at target lesions within 36, 48, and 60 months as reported by the site and adjudicated by the CEC.

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.