Total Occlusion With Angioplasty After Using a Radiofrequency Guide Wire-Magnetic-Coronary
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Stereotaxis
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Primary RF wire success
研究概览
简要总结
A single center Pilot Clinical Registry Study of the" Acute Procedural" Safety and Efficacy of Stereotaxis PowerAssert(TM)RF Coronary Total Occlusion System assisted Angioplasty in the Treatment of Refractory Coronary Total Occlusions
详细描述
Determine the safety and efficacy of the Stereotaxis PowerAssert™ 18 RF Wire System:
Primary - of recanalizing (crossing) coronary total occlusions within a stent.
Secondary - facilitated angioplasty at hospital discharge represented by
- Event free survival
- Anginal status, and
- Target vessel patency
- minimal luminal diameter (MLD).
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
- •Patient eligible for elective revascularization of a native coronary vessel
- •Patient has refractory coronary total occlusion (Thrombolysis In Myocardial Infarction (TIMI) 0 flow) within a stent
- •Written Informed Consent obtained
排除标准
- •Under 18 years of age
- •Current participation in another study with any investigational drug or device
- •>TIMI 0 flow at target lesion site
- •Lesion >40mm. in length
- •Factors making follow-up or repeat angiography difficult or unlikely
- •Acute myocardial infarction less than 1 month before angioplasty
- •Contra-indication to emergency coronary artery bypass surgery
- •No access to cardiac surgery
- •Contra-indication to treatment with aspirin, ticlopidine, clopidogrel or heparin
- •Angiographic evidence of thrombus (filling defect proximal to or involving the occlusion)
- •Occluded ostium of the right coronary artery or stem of left main coronary artery as target lesion
- •Totally occluded bypass graft as target vessel
- •Occlusion in an unprotected left main coronary artery
- •Ejection fraction less than 30%
- •Lesion beyond acute bends or in a location within the coronary anatomy where the catheter cannot traverse
- •Lesion within a bifurcation with a significant sidebranch >1.5mm in diameter
结局指标
主要结局
Primary RF wire success
时间窗: Assessed and measured during interventional procedure up to discharge-average hospital stay 1-5 days- defined in protocol as the number of days between interventional treatment and hospital discharge
Defined as reaching the true lumen of any branch distal to the total occlusion with the sole use of the RF wire with absence of major complications (Myocardial Infarction (MI), tamponade, emergency Cornary Artery Bypass graft (CABG) or death)
次要结局
- Facilitated RF wire Success: Procedure Success: Clinical Success(Assessed and measured during interventional procedure up to discharge-average hospital stay 1-5 days- defined in protocol as the number of days between interventional treatment and hospital discharge)