NCT01499329Unknown不适用
Endovascular Treatment of Iliac Artery Occlusions or Stenoses Using the Zeus CC Stent System
be Medical1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Binary (≥ 50%) restenosis rate
研究概览
简要总结
The purpose of this study is to evaluate safety and performance of the balloon-expandable Zeus CC (Rontis AG) stent for the treatment of Trans-Atlantic Inter-Society Consensus (TASC) A, B, C and D iliac lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient is older than 18 years
- •Patient must sign a written informed consent form that is approved by the ethics committee prior to index-procedure
- •Patient must be compliant with all follow-up visits
- •Patient suffers from intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4 and 5)
- •Patient's life expectancy is more than 2 years
- •Patient has iliac atherosclerotic de novo lesion(s) type A, B, C & D according to TASC-II classification
- •Target vessel diameter is between 5 and 9 mm
- •Target lesion has a baseline diameter stenosis of more than 50%
- •Patient has sufficient infra-inguinal run-off with at least a patent common femoral artery and deep femoral artery (both <50% stenosis)
排除标准
- •Patient has a life expectancy of less than 2 years
- •Patient is refusing to be compliant with all follow-up visits
- •Patient suffers from acute limb ischemia, defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
- •Patient is intolerant to anticoagulant or antiplatelet therapy such as aspirin, heparin, clopidogrel or ticlopidine drug therapy
- •Patient has already been treated with a stent in the ipsilateral target vessel
- •Patient suffered tissue loss in the target extremities, defined as Rutherford 6
- •Patient is already enrolled in this or another investigational device study
- •Patient had a coronary intervention within the last 60 days before enrolment into this study or there is a planned coronary intervention within 60 days of enrolment into this study
- •Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index-procedure
- •Any planned surgical intervention within 30 days of the index-procedure
- •Patient has an abdominal aortic aneurysm that is likely to require repair within the next 2 years.
- •Patient has no sufficient infra-inguinal run-off (>50% stenosis). Patient inclusion is only possible if revascularization (endovascular or surgical) is performed in the same procedure with a peroperative angiographic control yielding <30% stenosis.
- •Target lesion is a restenotic lesion.
- •Target lesion is adjacent an aneurysm.
- •Target vessel perforation with documented contrast extravasation during index-procedure prior to stent placement.
结局指标
主要结局
Binary (≥ 50%) restenosis rate
时间窗: 12, 24 months
assessed by duplex ultrasound at the target lesion without the need for repeat TLR after the index-procedure in surviving patients with preserved limbs
次要结局
未报告次要终点
研究者
研究点 (1)
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