The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months

From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Safety Endpoint were available for 268 subjects.

The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure.

• The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm).
• The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm).

From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Co-Primary Efficacy Endpoints were available for 268 subjects

The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month

From the 299 enrolled subjects, data for the Secondary Safety Endpoint was available for 297 subjects

• Technical success: ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
• Procedural success: technical success with no MAEs within 24 hours of the procedure

Primary patency is the percentage of lesions (target stented segments) that reach a time point without a hemodynamically significant stenosis assessed by Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or bypass of the target lesion.

From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Patency Analysis was available for 268 subjects/lesions

Assisted primary patency is the percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach a time point without restenosis.

From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Assisted Primary Patency Analysis was available for 256 subjects

Vascular InterVentional Advances (VIVA) definitions:

Grade 0: No strut fractures

Grade I: single strut fracture

Grade II: multiple strut fractures

Grade III: stent fracture(s) with preserved alignment of the components

Grade IV: stent fracture(s) with mal-alignment of the components

Grade V: stent fracture(s) in a trans-axial spiral configuration

From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Stent Fracture Analysis were available for 250 subjects

Class 0: Asymptomatic

Class 1: Mild claudication

Class 2: Moderate claudication

Class 3: Severe claudication

Class 4: Ischemic rest pain

Class 5: Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal edema

Class 6: Major tissue loss - extending above metatarsal (MT) level

Rate of Primary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR.

Rate of Secondary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR.

Rate of Clinical Deterioration: downgrade in Rutherford classification of one or more categories as compared to pre-procedure

From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Rutherford Classification Analysis was available for 263 subjects

The Ankle-Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm.

Hemodynamic Improvement: Increases in ABI of ≥ 0.10 or to an ABI ≥ 0.90 as compared to pre-procedure without the need for repeat TLR.

Hemodynamic Improvement (Including TLR): Increases in ABI of ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure including TLR.

278 subjects were included in the Rate of Hemodynamic Improvement Analysis (275 subjects eligible for the 12-Month Follow-Up + 3 subjects with TLR)

The Walking Impairment Questionnaire (WIQ) is a validated functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.

From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement assessed by the Walking Impairment Questionnaire were available for 265 subjects

Assessment of walking improvement (time) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.

From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects

Assessment of walking improvement (distance) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.

From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects

Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health). The SF-36 is a multipurpose, proprietary health survey with 36 questions that yield eight health component scales that can be further summarized into two summary scores: mental and physical health scores. The eight health component scales that can be computed from the questionnaire are physical function, role-physical, bodily pain, general health, vitality, role-emotional, mental health and social functioning.

From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Quality of Life Analysis were available for 265 subjects