Invest-CTO: Effectiveness and Safety of a Planned Investment Procedure in High-Risk CTO PCI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Compositie safety endpoint
研究概览
简要总结
Following unsuccessful CTO crossing a CTO modification procedure is sometimes performed. CTO PCI registries where plaque modification has been performed in some patients, report this to be safe, and associated with higher success rates at subsequent attempts.
It has never been investigated whether a planned investment procedure, with an intention that both the initial and staged completion PCI are of shorter duration, could improve safety and efficacy.
The investigators hypothesize that
- A planned investment procedure in the treatment of CTOs will be associated with improved patient safety
- A planned investment procedure will be associated with improved cumulative procedure success rates
- A planned two stage procedure will be associated with improved patient experience
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Ability to provide written informed consent
- •Comply with the procedural and study follow-up schedule
- •Planned CTO PCI in accordance with the European and American appropriateness criteria.
- •CTO defined as high-risk
排除标准
- •Non-high risk CTO
- •Occlusion within a stent
- •Flush aorto-ostial occlusion of RCA and Left Main (LMS)
- •Limited arterial access precluding repeat procedure
- •Baseline non invasive testing showing non-viable target vessel territory
- •Contra-indication to dual antiplatelet therapy
- •Pregnancy
- •Prior radiation skin injury
- •Lack of informed consent
研究组 & 干预措施
Invest CTO PCI
A pre-planned two staged procedure in high-risk CTO PCI
干预措施: Chronic total occlusion(CTO) percutaneous coronary intervention (PCI) (Procedure)
结局指标
主要结局
Compositie safety endpoint
时间窗: 30 days post procedure
Death, myocardial infarction and procedural related complications
Effectiveness
时间窗: Up to 12 weeks
CTO PCI Procedural success, Complete technical success plus the absence of an in-hospital major adverse cardiovascular event (MACE; death, MI, or clinically driven target vessel revascularization \[TVR\]
次要结局
- Seattle angina questionnaire (SAQ7)(Baseline, 3 & 12 months)
- CTO PCI technical success(At the end of staged CTO PCI completion procedure and within 3 months)
- CTO PCI investment procedural success(30 days post procedure)
- CTO PCI technical success(At the end of staged CTO PCI completion procedure and within 3 months)
- CTO PCI investment procedural success(30 days post procedure)
- Seattle angina questionnaire (SAQ7)(Baseline, 3 & 12 months)
- Compositie safety endpoint(30 days post procedure)
- Composite Clinical endpoint(30 days, 3 & 12 months)
- European Quality of Life-5 Dimensions(Baseline, 3 and 12 months)
- Patient related outcome measures (PROM)(Through study completion, an average of 15 months.)