NCT00733070终止不适用
A Multicenter Multinational Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
Ovalum5 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2008年8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
- 30
- 试验地点
- 5
- 主要终点
- Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications
研究概览
简要总结
A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained prior to any trial activities.
- •Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see
排除标准
- •Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to
- •Exclusion Criteria:
- •Patient unable to give informed consent.
- •Current participation in another study with any investigational drug or device.
- •Factors making follow-up and/or repeat angiography difficult or unlikely.
- •Contra-indication to emergency artery by pass surgery.
- •Lack of surgical backup.
- •Contra-indication to treatment with Aspirin, or Clopidogrel and/or Heparin.
- •Lesion > 40mm in length (both calcified lesion and adjacent thrombus).
- •Treated vessel referenced diameter less than 2.5 mm.
- •Visualization of the distal lumen less than the Rentrop Classification Grade 2 collateralization.
- •Non-visible entry point of target lesion.
- •Totally occluded bypass graft as target vessel.
- •Acute MI less than 1 week before procedure.
- •Patient has significant LV dysfunction, 35% LVEF or less.
- •Patient with cancer or other sever chronic disease with life expectance of 2 years.
- •Patient has chronic renal failure with serum creatinine ≥
- •Hemoglobin ≤
- •Patient is known or suspected not to tolerate the contrast agent.
- •Morbid Obesity (BMI > 40).
- •Drug abuse or alcoholism.
- •Patients under custodial care.
- •Pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.
结局指标
主要结局
Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications
时间窗: during procedure, 1day, 1week and 30 days post procedure
次要结局
- Successful stenting(During procedure, Day1, Day7 and Day30 post procedure)
- Wire crossing duration(during procedure)
- Fluoroscopy time(during procedure)
- Amount of contrast(during procedure)
- Maneuverability of the CiTop™ up to the occlusion(during procedure)
- No mechanical damage to the device during(during procedure)
研究者
研究点 (5)
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