Determination of Effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the Treatment of Infrainguinal Vessels/Lower Extremities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 主要终点
- Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)
研究概览
简要总结
The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.
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
- •Has a Rutherford Clinical Category Score of 1 -
- •Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography.
- •Has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot.
- •Exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion.
- •Each discrete target lesion's length is ≤ 20 cm.
- •Reference vessel diameter is ≥ 1.5 mm and ≤ 7 mm.
排除标准
- •Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.
- •Has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.
- •Has had a previous peripheral bypass affecting the target limb.
- •Has end-stage renal disease defined as undergoing hemodialysis for kidney failure.
- •Has presence of severe calcification in target lesion(s).
- •Has in-stent restenosis of the target lesion.
- •Has an aneurysmal target vessel.
- •Has significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel.
- •Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment.
- •Has disease that precludes safe advancement of the SilverHawk/TurboHawk device to the target lesion(s).
- •Has had a previous amputation above the metatarsal line on the target limb.
研究组 & 干预措施
Atherectomy
All patients enrolled in this single-arm study were treated with directional atherectomy.
干预措施: SilverHawk & TurboHawk Peripheral Plaque Excision System (Device)
结局指标
主要结局
Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)
时间窗: One year
The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 - 3) at time of enrollment.
Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6)
时间窗: One Year
The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 - 6) at time of enrollment.
次要结局
- Major Adverse Event Rate (in All Patients Enrolled)(One Year)
- Ankle-Brachial Index (in All Patients Enrolled)(1 Year)
- Device Success (in All Patients Enrolled)(Immediately following use of the SilverHawk device)
- Procedural Success (in All Patients Enrolled)(Immediately following use of the SilverHawk and adjunctive devices)
- Improvement in Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)(Baseline and 1 Year)
- Improvement in Rutherford Clinical Category (in All Patients Enrolled)(1 Year)
- Improvement in Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6)(3 months)
- Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3)(1 year)
- Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6)(One Year)
- Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3)(One Year)
- Secondary Patency (in Patients Treated for Claudication RCC 1-3)(One Year)
- Major Adverse Event Rate (in All Patients Enrolled)(30 Days)