NCT02169921已完成不适用
Determination of Safety and Effectiveness of the TurboHawk and the SpiderFX for the Treatment of Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries in Japan
Medtronic Endovascular4 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2014年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Primary Patency Rate
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the TurboHawk for the treatment of peripheral arterial disease (PAD) in the superficial femoral and/or the popliteal arteries with the Japanese population.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provides written informed consent
- •Willing to comply with follow-up evaluations at specified times
- •Has a Rutherford Clinical Category Score of 2-4
- •Disease located within the femoropopliteal artery
- •Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral and/or popliteal, confirmed by angiography
- •Each discrete target lesion's length is ≥4cm and ≤ 15 cm
- •Reference vessel diameter is ≥ 3.5 mm and ≤ 7.0 mm
排除标准
- •Previously implanted stent(s) or stent graft(s) in target leg
- •Life expectancy less than 12 months
- •Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure
- •Has in-stent restenosis of the target lesion
- •Has an aneurysmal target vessel
- •Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment
研究组 & 干预措施
TurboHawk
Experimental
This study is designed as a single arm study. For angioplasty, the Atherectomy Catheter, TurboHawk is used in this arm. Spider FX, the Distal Embolus Protection Device, can concomitantly be used with TurboHawk
干预措施: Atherectomy Catheter (Device)
结局指标
主要结局
Primary Patency Rate
时间窗: 180 Days
次要结局
- Technical procedural success(30 Days)
- Amputation Rate(30 Days , 180 Days and One Year)
- Improvement in Ankle-Brachial Index(30 Days , 180 Days and One Year)
- Improvement in Rutherford Clinical Category(30 Days , 180 Days and One Year)
- Preservation of the number of run-off vessels determined by angiography(intra operative)
- Event free survival(30 Days , 180 Days and One Year)
- Clinically driven target lesion revascularisation(30 Days , 180 Days and One Year)
- Clinically driven target vessel revascularisation(30 Days , 180 Days and One Year)
研究者
研究点 (4)
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