The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up

ITT

Percentage of participants in the amputation free survival population with Clinically driven Target Lesion Revascularization (CD-TLR) at 12 months, CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s).

Amputation free surviving meaning participants without an amputation at 12 months. This analysis population consists of 196 participants in the Drug Eluting Balloon arm and 107 participants in the Standard PTA arm.

Percentage of participants experiencing all cause death, major amputation and clinically driven Target Lesion Revascularization (CD-TLR) at 6 months. CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s)

Percentage based on number of evaluable subjects for safety events (232 participants in the drug eluting balloon arm and 114 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.

Percentage of participants with a 1 year amputation free survival.

Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.

Percentage of participants with completed wound healing, wound healing as defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.

Patients with pre-existing wounds and/or occurence of new wounds

Percentage of participants with a 1 year amputation free survival and wound healing. Wound healing is defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at a specified time point.

Percentage based on number of evaluable subjects for safety events (206 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.

Percentage of participants with an amputation free survival and resolved Critical Limb Ischemia (CLI) at 1 year.

Percentage based on number of evaluable subjects for safety events (205 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.

Percentage of participants that experienced death, amputation and clinically driven Target Lesion Revascularization (TLR) at 1 year.

Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.

Percentage of participants that experienced primary sustained clinical improvement at 1 year, specified as an improvement shift in the Rutherford classification of one class in amputation free, clinically driven target lesion revascularization (TLR) free surviving subjects.

Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects

Percentage of participants that experienced a secondary sustained clinical improvement, specified as an improvement shift in the Rutherford classification of one class including the need for clinically driven TLR in amputation free surviving subjects at 1 year.

Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects

Quality of life assessment by EQ5D at 1 year compared to baseline. EQ-5D is a standardised measure of health status and economic appraisal. The EQ-5D-3L essentially consists of 2 parts:the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

EQ-5D health states can be converted into a single summary index where 0.0='worst possible outcome' and 1.0='best possible outcome'.

Effectiveness Analysis sets - all randomized subjects with available data for EQ5D at baseline and 1 year

Walking Impairment assessment by WIQ at 1 year compared to baseline. The Walking Impairment Questionnaire (WIQ) is a questionnaire for evaluating walking impairment in patients with peripheral arterial disease (PAD). This can be used to identify patients with significant impairment and to monitor effectiveness of therapeutic interventions. The questionnaire was self-administered by the patients and contains three domains measuring three important factors of walking impairment in patients with intermittent claudication: (1) difficulty walking a distance during the past month, (2) difficulty walking at a certain speed during the past month, (3) symptoms associated with walking impairment. For each separate domain, a subscore was calculated. The total WIQ score was defined as the mean of the three subscores.

A WIQ score of 42.5 or less identified low performers; while a score of 75.5 or more identified high performers. The WIQ score range is 0 (minimum) - 100 (maximum).

Effectiveness Analysis sets - all randomized subjects with available data for Walking Impairment assessment at baseline and 1 year

Percentage of participants with a MAE (Major Adverse Events) at 1 year. Major Adverse Events, defined as Death of any Cause, Major Amputation of target limb, Minor Amputation of target limb

Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.

Percentage of device success defined as exact deployment of the device according to the instructions for use as documented with suitable imaging modalities

Number of device deployments

Percentage of technical success defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography

Number of device deployments

Percentage of patients with a procedural success defined as combination of technical success, device success and absence of procedural complications

All randomized subjects with available data

Days of hospitalization at 1 year

All randomized subjects with available data

Percentage of participants with an improvement in percent diameter stenosis (%DS) of the target leasion (TL) assessed by Quantitative Vascular Angiography (QVA)

Angiographic subgroup only. Angio-target lesion is one identifiable single solitary or series of multiple adjacent lesions with a diameter stenosis higher than 70% and a cumulative length less than 100 mm that can be covered by a single IN.PACT Amphirion™; and Angio-target lesion is the only lesion in that vessel.