NCT05868161招募中不适用
Pounce™ Thrombectomy System Retrospective Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 9
- 主要终点
- Procedural Success
研究概览
简要总结
The PROWL registry is an open-label retrospective, multi-center, US study of the Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Subject underwent an endovascular intervention where the Pounce Thrombectomy System was attempted
- •Subject is willing and able to provide informed consent prior to the collection of study data or a consent waiver is in place
排除标准
- •Subject is under the age of 18 years
结局指标
主要结局
Procedural Success
时间窗: Peri-procedural (by the end of the index procedure)
Restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment as determined by the core lab and physician
Incidence of device related Major Adverse Events (MAEs)
时间窗: Procedure to 30 days
Death, Unplanned major amputation (above ankle), Clinically Driven target lesion revascularization (TLR)
次要结局
- Primary vessel patency(30 days)
- Thrombo-aspiration in Peripheral Interventions (TIPI) flow rate(Peri-procedural (by the end of the index procedure))
- Characterize subject index procedure hospitalization course at discharge(Index procedure hospital admission to discharge, approximately 1 to 2 days)
- Completeness of thromboemboli removal (by angiography)(Peri-procedural (by the end of the index procedure))
- Underlying atheroma stenosis(Peri-procedural (by the end of the index procedure))
- Modified Society for Vascular Surgery (SVS) runoff(Pre-procedure, Peri-procedural (by the end of the index procedure))
- Describe index procedural characteristics(Peri-procedural (by the end of the index procedure))
- Adjunctive procedures(Peri-procedural (by the end of the index procedure))
- Rutherford classification (if applicable)(Baseline, at hospital discharge (approximately 1-2 days), 30 days)
- Incidence of index procedure access site complications(30 days)
- Technical success(Peri-procedural (by the end of the index procedure))
- Index procedure durations(Peri-procedural (by the end of the index procedure))
- Incidence of: Procedure-related SAEs Device-related (S)AEs(30 days)
- Rutherford class (if applicable)(Procedure to 30 days)
- Ankle Brachial Index (ABI)(Baseline to 30 days)
- Incidence of device related arterial AEs(30 days)
- Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR(30 days)
- Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device(30 days)
研究者
研究点 (9)
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