Evaluation of the GORE TIGRIS Vascular Stent in the Treatment of Atherosclerotic Lesions of the Superficial Femoral and Proximal Popliteal Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 267
- 试验地点
- 68
- 主要终点
- Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months
研究概览
简要总结
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomatic peripheral arterial disease (PAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rutherford Class 2 -
- •Abnormal ankle brachial index (ABI ≤0.9).
- •At least 21 years of age.
- •Reasonable expectation of survival of at least 12 months after the procedure.
- •Male, infertile female, or female practicing an effective method of preventing pregnancy.
- •One de novo or restenotic lesion of the SFA/PPA with a cumulative length visually estimated to be ≤24cm
- •Arteries with reference vessel diameter of 4.0 - 6.5 mm within the SFA/PPA, estimated visually.
- •Angiographic evidence of at least one patent tibial artery (<50% stenosis angiographically).
- •Guidewire has successfully traversed the lesion to be treated and is within the true lumen of the distal vessel.
- •Lesion has been pre-dilated before stent deployment.
排除标准
- •Prior enrollment in this study.
- •Vascular access/catheterization in the target leg within 30 days of study enrollment.
- •Prior treatment of the SFA/PPA in the target leg with stenting or bypass.
- •Flow-limiting aortoiliac disease.
- •Additional ipsilateral femoropopliteal or tibial disease, outside of the lesion to be stented, requiring intervention.
- •Arterial aneurysm in the target leg.
- •Co-morbid conditions which would preclude compliance with study protocol.
- •Obstructive or occlusive non-atherosclerotic disease.
- •Creatinine greater than 2.5 mg/dl.
- •Amputation above the metatarsals, resulting from vascular disease, in the target leg.
- •Septicemia or uncontrolled infection.
- •Contraindication to anticoagulation or antiplatelet therapy, including allergy to heparin, or history of heparin induced thrombocytopenia (HIT), or a positive platelet factor 4 (PF4) antibody assay.
- •Abnormal platelet levels, i.e., platelet count at Baseline less than 80,000/microliter.
- •History of coagulopathy.
研究组 & 干预措施
TIGRIS Vascular Stent
GORE TIGRIS Vascular Stent
干预措施: TIGRIS Vascular Stent (Device)
BARD LifeStent
BARD LifeStent
干预措施: BARD LifeStent (Device)
结局指标
主要结局
Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months
时间窗: 12 Months
Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation.
Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days
时间窗: 30 Days
Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation).
次要结局
- Number of Participants With Procedural Success(Within 48 hours of initial device implant)
- Number of Participants With Device Success(Immediately following initial device implant (usually within a few minutes to an hour).)