NCT00504088终止4 期
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
FoxHollow Technologies31 个研究点 分布在 1 个国家开始时间: 2006年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 试验地点
- 31
- 主要终点
- Major amputation-free survival
研究概览
简要总结
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Ischemic rest pain for more than 2 weeks or ulceration or gangrene of the foot or toes (Rutherford Becker Category 4, 5 or 6)
- •Willing and able, as evaluated by the PI, to provide Informed Consent
- •Willing to undergo up to 5 years of clinical follow up visits as scheduled
- •Angiographic pattern of infrainguinal disease that can be reasonably managed either by surgery or plaque excision in the first instance
- •Reconstitution of at least one patent target tibial segment below the knee which provides run-off to the foot
- •The patient must be >18 years of age
- •Target lesion(s) is located at or below the level of the superficial femoral artery
- •Target lesion(s) is >50% stenosed by quantitative vascular angiography
- •Ability to take at least one of the following types of medications: anti- platelet or anti-thrombotic therapy
排除标准
- •Patient has cardiac or cardiovascular comorbidities that would make surgery inappropriate
- •Patient has terminal or Stage 4 cancer
- •Patient has extensive gangrene that requires both a Below-the-Knee amputation and a revascularization procedure
- •Previous stent in the target lesion
- •Active infection at planned incision site
- •The patient is a pregnant woman
- •The patient has significant suprainguinal or Common Femoral disease that can not be treated either prior to or during the index procedure
- •Target Lesion is a Chronic Total Occlusion (CTO) that is greater than 15cm in length and has severe, continuous calcification
结局指标
主要结局
Major amputation-free survival
次要结局
未报告次要终点
研究者
研究点 (31)
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