MIMICS-2: Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System in the Femoropopliteal Arteries of Patients With Symptomatic Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 271
- 试验地点
- 73
- 主要终点
- Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
- •Known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR >1.
- •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.
结局指标
主要结局
Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE)
时间窗: 30 days
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.
Primary Effectiveness Endpoint (Primary Stent Patency Rate)
时间窗: 12 months
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.
次要结局
- Clinical Outcome (Six-Minute Walk Test)(Baseline, Day 30, Months 12 & 24)
- Number of Participants With Serious Adverse Events(36 Months)
- Long Term Safety (Overall MAE Rate at Month 12)(12 months)
- Number of Participants With Improvement of Rutherford Clinical Category by 1 or More(Baseline, Day 30, Months 12 & 24)
- Functional Outcome (Ankle Brachial Index (ABI) Measurement)(Baseline, Day 30, Months 12 & 24)
- Number of Participants With Freedom From Stent Fracture(Months 12, 24 & 36)
- Secondary Safety (Overall MAE Rate at 30 Days)(30 Days)
- Technical Success(Procedural (at end of index procedure))
- Primary Stent Patency(Months 12 & 24)
- Change of Walking Impairment Questionnaire Score(Baseline, Day 30, Months 12 & 24)