Freedom from a composite of major adverse events (MAE) comprising death, any major amputation performed on the target limb or clinically-driven target lesion revascularization (TLR) through 30 days.

Subjects with available 30 day follow-up

The primary effectiveness endpoint of the MIMICS-2 Study was defined as the primary stent patency rate at 12 months. Patency was defined as no significant reduction in luminal diameter (< 50% diameter stenosis) since the index procedure. Loss of patency was determined by an independent core laboratory when the peak systolic velocity ratio (PSVR) exceeds 2.0, or where angiography revealed > 50% diameter stenosis, or where the subject had a CDTLR.

Subjects were included in analysis population if they had imaging data qualifying as a 12m visit and/or subjects without imaging data who experienced a CDTLR through 12 months. Additionally, if a subject is missing stent patency status at the 12m window but found to be patent at a later out-of-window date, subject was considered patent at 12 months

Contribution of individual MAE rates for death, major amputation performed on the target limb and clinically-driven target lesion revascularization to the overall MAE rate at 30 days.

Subjects with available 30 day follow-up

Overall MAE rate at Month 12 and contribution of individual event rates to the overall MAE.

Subjects are included in the analysis population if (i) they have sufficient follow-up (at least 12 months less 30 days), or (ii) they have had the event of interest (each event is considered separately).

Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.

Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure

Subjects with available baseline angiography

Determined at Months-12 and 24 using values of: PSVR >2.0, >2.4; >2.5; and >3.5, each to indicate loss of patency on duplex ultrasound or where angiography reveals >50% diameter stenosis or where the subject undergoes clinically-driven TLR.

Further analysis of the patency data purely using a reference PSVR of >2.4, >2.5 and >3.5 was not feasible from the data that was collected.

Relevant data was not collected to provide the outcome analysis

Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 and 24.

Categories 0 - Asymptomatic

1. - Mild claudication
2. - Moderate claudication
3. - Severe claudication
4. - Ischemic rest pain
5. - Minor tissue loss
6. - Major tissue loss

Number of participants participating in the study changed at 30 Days, 12 Months and 24 Months

Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only).

Number of participants analysed changed over the time period

Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.

Number of participants assessed for ABI index measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.

Comparison of the Walking Impairment Questionnaire at Baseline, within 30 days after index procedure, then at Months 12 and 24.

The WIQ consists of 3 primary categories assessing walking distance, stair-climbing, and walking speed, as previously described. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (unable) to 4 (none).

Walking Impairment Questionnaire score at Baseline, within 30 days after index procedure, then at Months 12 and 24.

Stent integrity measured as freedom from fracture, defined as clear interruption of a stent strut observed in a minimum of two projections, determined by core lab examination of X-rays taken with the leg in extension at 12, 24 and 36 Months.

Number of participants with no fracture in study stent at 12, 24 and 36 Months assessment.