BOLT Lithotripsy RESTORE BTK Trial for PAD (RESTORE BTK)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Composite of new-onset Major Adverse Events (MAEs)
研究概览
简要总结
The RESTORE (BTK) below 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 (BTK) below 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 -
- •Single or multiple target lesion(s) is/are located in a de novo artery distal to the trifurcation vessels and extends to and ends above the ankle
- •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
- •Target lesion is within only lower extremity vessel with < 50% stenosis.
- •Significant stenosis (>50% stenosis) or occlusion of inflow tract (e.g., iliac or common femoral) not successfully treated with PTA, stent or Lithotripsy and without complications
- •Planned major amputation of the target leg.
- •Previously implanted stent in the treatment lesion
结局指标
主要结局
Composite of new-onset Major Adverse Events (MAEs)
时间窗: Within 30 days following procedure
Primary Safety Endpoint
Acute reduction in percent (%) diameter stenosis of target lesion
时间窗: Immediately after the intervention/procedure/surgery
Primary Effectiveness Endpoint
Acute reduction in percent (%) diameter stenosis of target lesion
时间窗: Immediately after the intervention/procedure/surgery
Primary Effectiveness Endpoint
Composite of new-onset Major Adverse Events (MAEs)
时间窗: Within 30 days following procedure
Primary Safety Endpoint
次要结局
- Procedural success, defined as the ability of the Bolt IVL System to achieve a post-Lithotripsy residual diameter stenosis of ≤50% (with or without adjunctive PTA therapy or stenting)(Immediately after the intervention/procedure/surgery)
- Procedural success, defined as the ability of the Bolt IVL System to achieve a post-Lithotripsy residual diameter stenosis of ≤50% (with or without adjunctive PTA therapy or stenting)(Immediately after the intervention/procedure/surgery)