NCT00618020已完成不适用
A Feasibility Study to Evaluate the Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusion in Coronary Arteries
Ovalum2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2007年8月1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
- 10
- 试验地点
- 2
- 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
The CiTop™ guidewire Coronary study is a feasibility open label study, to evaluate the safety and efficacy of the CiTop™ 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 (2)
Loading locations...
相似试验
终止
不适用
Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial FibrillationParoxysmal Atrial FibrillationNCT01103674nContact Surgical Inc.1
终止
不适用
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial FibrillationAtrial FibrillationNCT01103661nContact Surgical Inc.7
终止
不适用
Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTOCatheterization, PeripheralNCT00482742Ovalum50
已完成
不适用
Feasibility Study of the Magnetic Anal Sphincter (FENIX System)Fecal IncontinenceNCT01625221Torax Medical Incorporated35
Unknown
不适用
Feasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary SyndromeRefractory Thrombus in Patients With Acute Coronary SyndromeNCT04692402Paul Ong51