BOLT Lithotripsy RESTORE ATK Trial for PAD (RESTORE ATK)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 14
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
The RESTORE (ATK) above the knee study is a prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy System.
详细描述
The RESTORE (ATK) above the knee study is a prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy System that was designed to enhance percutaneous transluminal angioplasty by utilizing delivery of intravascular lithotripsy (IVL) to disrupt calcium prior to full balloon dilatation at low pressures.
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
- •Age of subject is ≥
- •Rutherford Clinical Category 2, 3, or
- •Target lesion that is located in a native de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery)
- •Calcification is at least moderate. (presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion or absolute length ≥20mm.
排除标准
- •Planned major amputation of the target leg (above the ankle)
- •The use of chronic total occlusion (CTO) re-entry devices
- •CTOs greater than 80 mm in length
- •Lesions within 10 mm of ostium of the SFA
- •Significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g., iliac or common femoral) not successfully treated with percutaneous angioplasty (PTA) or stent and without complications
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: Immediately after the intervention/procedure/surgery
Post-treatment residual diameter stenosis of \< 50% of the target lesion (with or without adjunctive PTA therapy and/or stenting)
Primary Safety Endpoint
时间窗: Within 30 days following procedure
Composite of New-onset Major Adverse Events (MAEs)
次要结局
- Ankle-Brachial Index (ABI) of the target limb at all planned follow-up time points(at discharge after index procedure, 30 days following procedure, 6 months following procedure)
- Freedom from Major Adverse Events (MAEs) within 6 months.(Within 6 months following procedure)
- Residual diameter stenosis of <50% of the target lesion (without adjunctive PTA or stent therapy)(Immediately after the intervention/procedure/surgery)
- Residual diameter stenosis of <30% of the target lesion (without adjunctive PTA or stent therapy)(Immediately after the intervention/procedure/surgery)
- Freedom from Target Lesion Revascularization (TLR) at 6 months(6 months following procedure)
- Target lesion patency - freedom from > 50% restenosis (assessed by DUS)(6 months following procedure)