NCT00205790已完成不适用
Comparison of Primary Patency Between GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts
W.L.Gore & Associates36 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2003年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 36
- 主要终点
- Primary patency at 12 months
研究概览
简要总结
To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence.
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
- Single
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
- •Patient requires primary above-knee bypass where the proximal anastomosis will be to the common femoral or proximal superficial femoral artery and the distal anastomosis will be the popliteal artery proximal to the medial head of the gastrocnemius;
- •Patient has Grade III or IV occlusive vascular disease;
- •Patient has a postoperative life expectancy greater than one year;
- •Patient is at least 21 years of age;
- •Patient is able to comply with all study requirements and be available for follow-up visits at 1 month, 6 months and 12 months post procedure;
- •Patient is willing and able to provide written, informed consent.
排除标准
- •Patient had a previous bypass in the diseased extremity (below iliacs);
- •Patient has known coagulation disorders including hypercoagulability;
- •Patient has had any previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin;
- •Patient has an acute embolic arterial occlusion;
- •Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
- •Patient had percutaneous transluminal angioplasty to the implant site within the previous 30 days;
- •Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure;
- •Patient has active infection in the region of graft placement; or
- •Patient has an incomplete preoperative assessment (as outlined in this protocol) due to an emergency procedure, a traumatic injury or any other reason.
结局指标
主要结局
Primary patency at 12 months
Major device complication rates at 12 months
次要结局
- Technical failures
- Secondary patency
研究者
研究点 (36)
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