Determination of Safety and Effectiveness of the SilverHawk™ Peripheral Plaque Excision System for Calcium (SilverHawk LS-C) and the SpiderFX™ Embolic Protection Device for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries (DEFINITIVE Ca++)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 主要终点
- Successful Revascularization
研究概览
简要总结
This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™ plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in treatment of moderate to severely calcified peripheral arterial disease in the superficial femoral and/or popliteal 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
- 18 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 leg pain due to peripheral arterial disease
- •Disease located within the femoropopliteal artery
- •Moderate to severe calcification
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
结局指标
主要结局
Successful Revascularization
时间窗: at the end of the procedure
Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory
Major Adverse Event Free Rate 30 Days
时间窗: 30 Days
MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).
次要结局
- Preservation of Run-off Distal to the Filter(at the end of the procedure)
- Technical Procedural Success(at the end of the procedure)
- Presence of Debris in Deployed SpiderFx™ Embolic Protection Device(at the end of the procedure)
- Residual Diameter Stenosis(at the end of the procedure)