Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System

Study Overview
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Brief Summary
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To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery. It is a prospective, single-arm, multicenter clinical trial.

Detailed Description
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The BioMimics 3D stent is intended to improve luminal diameter in the treatment of symptomatic de-novo, obstructive or occlusive lesions in native femoropopliteal arteries with reference vessel diameters ranging from 4.0 - 6.0 mm. Subjects with symptomatic atherosclerotic disease of the femoropopliteal artery who comply with all study eligibility criteria may be considered for enrollment.

Official Title
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MIMICS-2: Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System in the Femoropopliteal Arteries of Patients With Symptomatic Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: BioMimics 3D Vascular Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion of the native femoropopliteal artery. PAD classified as Rutherford clinical category 2, 3 or 4. Resting ankle-brachial index (ABI) of ≤0.90 (or ≤0.75 after exercise of the target limb) or angiographic or DUS evidence of >/= 60%. Single or multiple stenotic or occlusive lesions within the native femoropopliteal artery (target lesions) that can be crossed with a guidewire and fully dilated. Single or multiple target lesions must be covered by a single stent or two overlapping stents. Target lesion(s) eligible for treatment at least 1 cm distal to the origin of the deep femoral artery and at least 3 cm above the bottom of the femur. Target lesion(s) reference vessel diameter is between 4.0 mm and 6.0 mm. Single or multiple target lesions measure ≥40 mm to ≤140 mm in overall length, with ≥60% diameter stenosis by operator's visual estimate. Patent popliteal artery (no stenosis ≥50%) distal to the treated segment. At least one patent infrapopliteal vessel (<50% stenosis) with run-off to the ankle. Exclusion Criteria: Iliac stent in target limb that has required re-intervention within 12 months prior to index. Target vessel that has been treated with bypass surgery. PAD classified as Rutherford clinical category 0, 1, 5 or 6. Known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR >1.8. Stroke diagnosis within 3 months prior to enrollment. History of unstable angina or myocardial infarction within 60 days prior to enrollment. Thrombolysis within 72 hours prior to the index procedure. Acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L), or on peritoneal or hemodialysis. Significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤30% residual stenosis, without complication). No patent (≥50% stenosis) outflow vessel providing run-off to the ankle. Target lesion(s) requires percutaneous interventional treatment, beyond standard balloon angioplasty alone, prior to placement of the study stent.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioMimics 3D Vascular Stent<br>Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Vascular Stent System | Device: BioMimics 3D Vascular Stent System<br>* Femoropopliteal stenting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE) | 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. | 30 days | 
| Primary Effectiveness Endpoint (Primary Stent Patency Rate) | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety (Overall MAE Rate at 30 Days) | 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. | 30 Days | 
| Long Term Safety (Overall MAE Rate at Month 12) | Overall MAE rate at Month 12 and contribution of individual event rates to the overall MAE. | 12 months | 
| Number of Participants With Serious Adverse Events | Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36. | 36 Months | 
| Technical Success | Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure | Procedural (at end of index procedure) | 
| Primary Stent Patency | 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. | Months 12 & 24 | 
| Number of Participants With Improvement of Rutherford Clinical Category by 1 or More | Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 and 24. Categories 0 - Asymptomatic - Mild claudication - Moderate claudication - Severe claudication - Ischemic rest pain - Minor tissue loss - Major tissue loss | Baseline, Day 30, Months 12 & 24 | 
| Clinical Outcome (Six-Minute Walk Test) | Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only). | Baseline, Day 30, Months 12 & 24 | 
| Functional Outcome (Ankle Brachial Index (ABI) Measurement) | Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24. | Baseline, Day 30, Months 12 & 24 | 
| Change of Walking Impairment Questionnaire Score | 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). | Baseline, Day 30, Months 12 & 24 | 
| Number of Participants With Freedom From Stent Fracture | 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. | Months 12, 24 & 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, PVD, SFA stent