NCT01962389撤回1 期
First in Human Study of Winsor Laser Catheter
Spectranetics Corporation1 个研究点 分布在 1 个国家开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥ 18 years.
- •Rutherford Category 2-
- •Subject has been informed of the nature of the study, agrees to participate and has signed an Ethics Committee approved informed consent form.
- •Documentation of significant ISR defined as >50% stenosis and >5 cm in length determined by diagnostic angiogram or duplex ultrasound.
- •A previously deployed bare nitinol stent(s) in the femoropopliteal segment extending from the ostium of the SFA to 1 cm above the tibioperoneal trunk. A guidewire has successfully traversed the target treatment segment, or is able to cross using standard support catheter crossing techniques, is angiographically documented to be within true lumen and not placed through stent struts. Guidewire access may obtained via contralateral, ipsilateral or retrograde approach. If a retrograde guidewire approach is used to cross the target lesion, guidewire exchange and an antegrade approach is required prior to treatment with the Winsor Laser Catheter.
- •One or more patent tibial vessel(s) defined as <50% stenosis thoughout the segment with outflow to the foot.
- •Successful treatment of any inflow lesion(s) defined as final residual stenosis <30%.
排除标准
- •Patient is pregnant.
- •Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.
- •Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.
- •Crossing devices other than guidewire support catheters.
- •Type 4 or 5 stent fracture as assessed by angiography.
- •Target lesion is located within a covered stent.
- •Acute limb ischemia
结局指标
主要结局
Primary Safety Endpoint
时间窗: up to 48 hours
Freedom from Major Adverse Events (MAE) through hospital discharge: * All-cause peri-procedural death * Target limb amputation (above or below the ankle) * Target limb re-intervention * Target limb-related death
次要结局
- Efficacy(During Interventional Procedure)
研究者
研究点 (1)
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