Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 13
- 主要终点
- Minimal lumen area
研究概览
简要总结
The objective of PERFECTO is to assess the reendothelialization at 3 months after successfully CTO percutaneous intervention (PCI) with new generation drug eluting stent (DES) by OFDI analysis. Designed as a multicentric, observational and prospective study which will be conducted at University Hospital of Poitiers (France), a systematic OFDI analysis will be realized immediately after CTO-PCI and at 3 months. Known as major predictive factors of stent thrombosis, percentages of malapposition, uncovered struts and neointimal hyperplasia proliferation will be measured over the entire length of each stent implanted combining in a composite primary endpoint.
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
- •Successfully CTO revascularization by PCI with immediate post-PCI OFDI analysis
- •3 months follow-up with OFDI analysis of the recanalized coronary artery
- •Aged 18 or over
- •Written informed consent
排除标准
- •Contraindication or impossibility to realize a safety coronary OFDI (severe tortuosities)
- •Severe renal insufficiency (creatinine clearance < 30 ml/min)
- •Pregnancy or women with child-bearing potential
- •Bacteriemia or septicemia
- •Severe hemodynamic instability
- •Severe coagulation disorders
结局指标
主要结局
Minimal lumen area
时间窗: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Minimal lumen diameter
时间窗: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted
Percentage of uncovered stent struts
时间窗: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. (Number uncovered struts x 100)/total number of struts.
Thrombus
时间窗: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Percentage of malapposed stent struts
时间窗: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. (Number of malapposed struts x 100)/total number of struts.
Percentage of neointimal hyperplasia proliferation
时间窗: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. \[(minimal stent area - minimal lumen area)/minimal stent area\]x100.
Edge dissection
时间窗: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
次要结局
- Impact of the technique employed for CTO revascularization on the reendothelialization(3 months)
- Angina(One year)
- Dyspnea(One year)
- Relevancy of immediate post-PCI OFDI analysis(Day one)
- One year clinical follow-up(One year)