NCT00482742终止不适用
A Feasibility, Multi Center Multinational Randomized Open Label Study, to Evaluate the Safety and Performance of the CiTop™ Guidewire for Crossing Total Occlusion in Peripheral Arteries.
Ovalum6 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2006年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 6
研究概览
简要总结
The main objectives of the study are:
To evaluate the performance and safety of the CiTop guidewire, while attempting to cross thru total occlusions of various dimensions and morphology.
To compare the safety and efficacy of the CiTop guidewire with standard guidewires in terms of impact on the treated artery. Following operation of the CiTop device, angiography demonstrated successful crossing of the occlusion with no visible evidence of arterial wall injury, dissection, or distal embolization.
To assess ease of operation and the level of integration of the CiTop with standard interventional angiography procedure: Balloon angioplasty, placement of stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with symptomatic peripheral vascular disease, intermittent claudication less than 30 meters, rest pain or tissue ischemia.(Fontain grade 3-4)
- •Critical limb Ischemia
- •The patient has Chronic Total Occlusion in limb arteries, aged at least 3 months.
- •Patient has chronic total occlusion (CTO) that is:
- •Documented angiographically, by the investigator or co-investigator.
- •CTO was defined as an obstruction of a main peripheral artery with no luminal continuity and with TIMI (Thrombolysis In Myocardial Infraction) flow grade of 0 or
- •CTO location suitable for endovascular treatment (not in parallel location with the hip or knee joints).
- •Lesion ≤ 8cm in length
- •Lesion located in a segment with diameter more than 1.5 mm
- •Adequate compliance with follow-up and/or repeat angiography
- •No Contra-indication to treatment with aspirin or ticlopidine or clopidogrel and/or Heparin
- •Visible entry point of target lesion
- •NO cancer or other life threatening diseases or conditions
- •NO diagnosis or suspected renal failure (2 x ULN of creatinine)
- •Not suspected intolerance of the contrast agent
- •NO Drug abuse or alcoholism
- •Patients is NOT under custodial care
- •Women with childbearing potential are NOT pregnant (positive pregnancy test at the time of procedure).
排除标准
- 未提供
研究者
Liat Shochat
investigator
Ovalum
研究点 (6)
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