Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D

Primary Safety Endpoint: Number of participants free from a composite of major adverse events (MAE) comprising death, any major amputation performed on the index limb or clinically-driven target lesion revascularization (CDTLR) through 30 days.

Primary Effectiveness Endpoint: Number of participants free from clinically-driven target lesion revascularization (CDTLR) through 12 months.

Acute Technical Success: Number of participants with a final residual diameter stenosis ≤30% within 72 hours of the index procedure.

Acute Procedural Success: Number of participants with acute technical success (achievement of a final stenosis ≤30% at the end of the procedure) and absence of the following adverse events: 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 index procedure.

A Kaplan-Meier (KM) analysis of individual components of MAE (death, any major amputation performed on the index limb or CDTLR) through 24 months.

Overall rate of all adverse events reported from Day 0 through 24 months. An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in participants, whether or not related to the investigational device or procedure. For the purpose of this Study all potentially device-related and procedure-related adverse events, major adverse events (death, major amputation on the target limb, clinically-driven target lesion revascularisation), all vascular adverse events in the target limb, and serious adverse events are reported throughout the Study.

Per Protocol, patency is defined as the composite of freedom from more than 50% restenosis within the stented segment as observed by Duplex Ultrasound or Angiography within the visit window and freedom from clinically-driven target lesion revascularisation prior to the indicated time point. Stent patency rate assessed by duplex ultrasound (DUS), as available, determined at Months 12 and 24. This will be assessed using values of peak systolic velocity ratio (PSVR) >2.0, >2.4; >2.5; and >3.5. PSVR values of >2.0, >2.4, >2.5 and >3.5 were selected to compare outcomes from similar studies. There are no official definitions or guidelines on these values and which are most accurate for detection of >50% stenosis, so all have been used in the analyses to compare results from other studies. PSVR of >2.4, was looked at further as there are some studies that state this is the most established threshold for the detection of >50% stenosis (Schlager, et al. 2007).

Clinical Outcome: Comparison of Rutherford Clinical Category (RCC) measured at Baseline, Day 30, Months 12 and 24. Rutherford Clinical Category is a clinical scale identifying three grades of claudication (RCC 1-3) and three grades of critical limb ischemia (RCC 4-6) ranging from rest pain alone to minor and major tissue loss. Category and clinical description: 0 - Asymptomatic, 1 - Mild claudication 2 - Moderate claudication, 3 - Severe claudication, 4 - Ischemic rest pain, 5 - Minor tissue loss, 6 - Ulceration or gangrene.

Functional outcome: Mean and standard deviation of the Ankle Brachial Index at each follow-up visit is reported.

The change of Ankle Brachial Index at 30 days, 12 and 24 months compared to Baseline is presented for the total number of patients where data were recorded, and the mean and standard deviation of the change.

ABI is the ratio of blood pressure measured at the ankle to blood pressure measured at the arms. It is used to predict the severity of peripheral arterial disease. An ABI of >0.9-1.2 is considered normal, ≤ 0.9 indicates mild to moderate peripheral arterial disease, < 0.4 indicates severe peripheral arterial disease (ischemic pain and ulceration).

Site reported number of participants with stent fracture through 24 months. Stent fracture is defined as clear interruption of stent strut observed in a minimum of two projections, determined by examination of X-ray images.

Stent Strut Fracture Types: Type 0: No strut fractures. Type I: Single strut fracture only. Type II: Multiple single strut fractures that can occur at different sites. Type III: Multiple strut fractures resulting in complete transection of the stent, without displacement of the stent segments. Type IV: Multiple strut fractures resulting in displacement of segments of the stent. Type V: Spiral strut fracture.