The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 287
- 主要终点
- Primary Patency
研究概览
简要总结
This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.
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
- •Stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries.
- •Symptomatic femoral-popliteal atherosclerosis.
- •Willing to comply with all follow-up evaluations at the specified times.
- •Provides written informed consent prior to enrollment in the study.
排除标准
- •Previously implanted stent(s) or stent graft(s) in the target vessel.
- •Planned use of devices other than angioplasty balloons during procedure.
- •Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure.
- •Life expectancy of less than 12 months.
- •Symptomatic femoral disease in the opposite limb.
研究组 & 干预措施
PTA and Stenting with EverFlex device
Qualified subjects undergo treatment of atherosclerotic lesions in the native SFA/SFA/PPA with PTA and stenting using the PROTÉGÉ® EverFlex™ Self-Expanding Stent System
干预措施: PROTÉGÉ® EverFlex™ Self-Expanding Stent System (Device)
结局指标
主要结局
Primary Patency
时间窗: 1 Year
Primary stent patency, as determined by the core laboratory, was defined as PSV ratio \< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.
Major Adverse Events
时间窗: 30 Days
Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)
次要结局
- Major Adverse Events(1 Year)
- Number of Participants With Decline in Rutherford Clinical Category(30 days)
- Single-Stent Major Adverse Events(30 Days)
- Single-Stent Primary Patency(1 Year)
- Secondary Patency(1 Year)
- Absolute Claudication Distance Improvement(1 Year)
- Walking Improvement(1 Year)
- Duplex Ultrasound ≤ 2.4 Primary Patency(1 Year)
- Stent Fracture Rate(1, 2 and 3 Years)
- Improvement in Rutherford Clinical Category(1 year)
- Increase in Ankle-Brachial Index From Baseline to 1 Year(1 Year)
- Assisted Primary Patency(1 Year)