A Prospective, Single Arm, Multi-Center Study to Assess Performance of the Pathway PV Atherectomy System During Percutaneous Peripheral Vascular (PV) Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 主要终点
- Major Adverse Events (MAEs) Within 30 Days
研究概览
简要总结
The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature.
This is a prospective, single arm, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the lower limb peripheral vasculature.
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
- •Documented symptomatic atherosclerotic peripheral vascular disease
- •Target lesion(s) is/are located in a superficial femoral, popliteal and/or infrapopliteal arteries
- •The patient has been informed of the nature of the study and has provided informed consent
- •The patient agrees and has capability to meet study requirements and be present at the follow-up clinic visits
排除标准
- •Target lesion is located in the iliac artery.
- •Target lesion stenosis is < 70%.
- •Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
- •Patient is unable to participate for the duration of the study.
- •Patient is currently participating or has participated in a study with another investigational medical device or medication.
结局指标
主要结局
Major Adverse Events (MAEs) Within 30 Days
时间窗: 30 days
Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.
次要结局
- Average Rutherford Classification Score at 6 Months(6 months)
- Average Ankle Brachial Index (ABI) at 6 Months(6 months)
- Freedom From Target Lesion Revascularization (TLR) at 6 Months(6 months)