NCT05158686已完成不适用
Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty: The IMPROVED-RECTO Trial.
Ignacio J. Amat Santos1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年10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
- 44
- 试验地点
- 1
- 主要终点
- Success of repeated percutaneous coronary intervention of a CTO 3 to 6 months after balloon angioplasty proximal to the persistent lesion.
研究概览
简要总结
Observational retrospective registry to compare effectiveness of paclitaxel-coated vs. non coated balloon angioplasty proximal to a Chronic Total Occlussion (CTO) after failed revascularization. Primary objective is to determine success rate after repeated percutaneous coronary intervention of a CTO 3 to 6 months after paclitaxel-coated balloon angioplasty proximal to the persistent lesion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Failed recanalization of a CTO in patients with clinical indication for the percutaneous procedure.
- •Patient willing to participate in the study providing signed informed consent.
- •J-CTO Score ≥2.
排除标准
- •Unfeasible recanalization of the CTO according to the interventional cardiologists of the center.
结局指标
主要结局
Success of repeated percutaneous coronary intervention of a CTO 3 to 6 months after balloon angioplasty proximal to the persistent lesion.
时间窗: 6 months
次要结局
- Quality of life assessed by EQ5D questionnaire(6 months)
- Mortality after second attempt of CTO recanalization(6 months)
- Radiation during second attempt(6 months)
- Contrast administration during second attempt(6 months)
- Events at 1-year follow-up(1 year)
- Procedural duration during second attempt(6 months)
研究者
Ignacio J. Amat Santos
Coordinator of Interventional Cardiology Unit
Hospital Clínico Universitario de Valladolid
研究点 (1)
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