NCT01246505已完成3 期
Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
BridgePoint Medical11 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2011年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 11
- 主要终点
- Incidence of Patients with a Major Adverse Events (MAE)
研究概览
简要总结
Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.
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
- •suitable candidate for non-emergent, peripheral angioplasty
- •documented de-novo or restenotic peripheral CTO lesion with TIMI 0 flow for at least 90 days and satisfactory distal vessel visualization (collateral supply)
- •limb ischemia or claudication, Rutherford class I-III (grade 1-5) caused by the occluded artery
排除标准
- •intolerance to aspirin or a neutropenic response to Ticlopidine or Clopidogrel
- •appearance of thrombus or intraluminal filling defects
- •peripheral intervention in the target limb within two weeks of the procedure
- •renal insufficiency (serum creatinine of > 2.3 mg/dl)
- •contraindication to a peripheral artery intervention
- •participation in another investigational protocol
结局指标
主要结局
Incidence of Patients with a Major Adverse Events (MAE)
时间窗: 30 Day
MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication.
Incidence of Intraprocedural Technical Success
时间窗: Intraprocedural (<24 hours)
Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO
次要结局
未报告次要终点
研究者
研究点 (11)
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