NCT01680835已完成不适用
The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the EverfLex NitInol STent System Post Approval Study
Medtronic Endovascular46 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2013年1月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 46
- 主要终点
- Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization
研究概览
简要总结
This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria
- •Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts), or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries suitable for primary stenting.
- •Has a Rutherford Clinical Category Score of 2, 3 or
- •Is willing to comply with all follow-up evaluations at the specified times.
- •Is ≥ to18 years old.
- •Provides written informed consent prior to enrollment in the study.
- •Angiographic Inclusion Criteria Subjects must meet all of the following angiographic inclusion criteria. The implanting physician bases all angiographic inclusion criteria on visual determination at the time of the procedure.
- •Target lesion(s) located within the native SFA/proximal popliteal: distal point at least 3 cm above the cortical margin of the femur and proximal point at least 1 cm below the origin of the profunda femoralis measured by straight posteroanterior (PA) view for distal lesions, ipsilateral oblique view for proximal lesions.
- •Evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s).
- •Target lesion(s) total length is ≥ 4 cm and ≤ 18 cm.
- •Target vessel diameter is ≥ 4.5 mm and ≤ 7.5 mm.
- •There is evidence of at least one runoff vessel to the ankle/foot of the limb to be treated that does not also require treatment for significant (> 50% stenosis or occlusion) stenosis during the index procedure.
排除标准
- •Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.
- •Has a contraindication or known allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, contrast media or any other drug used in study according to the protocol.
- •Has known hypersensitivity to nickel-titanium.
- •Has bleeding diathesis, coagulopathy, known hypercoagulable condition, or refuses blood transfusion.
- •Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures.
- •Has life expectancy of less than 1 year.
- •Has planned use of thrombectomy, atherectomy, brachytherapy or laser devices during procedure.
- •Has previously been enrolled in the DURABILITY PAS study.
- •Has received endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure.
- •Has any planned surgical intervention or endovascular procedure 14 days before or 30 days after the index procedure.
- •Is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- •Has any co-morbid condition that precludes endovascular treatment.
- •Angiographic Exclusion Criteria The subject must not meet any of the following angiographic exclusion criteria. The implanting physician bases all angiographic exclusion criteria on visual determination at the time of the procedure.
- •Exchangeable guidewire cannot cross the target lesion and/or re-enter true vessel lumen distal to lesion(s).
- •Presence of significant (> 50% stenosis or occlusion) ipsilateral common femoral stenosis.
- •Aneurysmal target vessel.
- •Presence of an acute intraluminal thrombus at the proposed lesion site.
- •Perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to start of PTA procedure.
- •Focal popliteal disease in the absence of femoral disease.
结局指标
主要结局
Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization
时间窗: 3 Years
Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.
次要结局
- Secondary Outcome - Number of Participants Free From Acute Death(30 days)
- Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year(1 Year)
- Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year(1 Year)
- Secondary Outcome - Number of Successfully Implanted Stents(At procedure)
- Secondary Outcome - Freedom From Stent Fracture(1, 2 and 3 years)
- Secondary Outcome - Freedom From 36-month Amputation(3 Years)
- Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years(1 and 2 years)
- Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization(3 Years)
- Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year(1 Year)
- Secondary Outcome - Number of Adverse Events(3 Years)
研究者
研究点 (46)
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