The Evaluation of a Strategy to PREPARE Severely CALCified Coronary Lesions With a Combination Of Rotational Atherectomy and Modified BallOons Trial (PREPARE-CALC- COMBO)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary endpoint: Numerical in-stent acute lumen gain in mm
研究概览
简要总结
A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.
详细描述
A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Clinical inclusion criteria
- •Age above 18 years and consentable
- •Angiographically proven coronary artery disease
- •Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve
- •Written informed consent
- •Angiographic inclusion criteria
- •De-novo lesion in a native coronary artery
- •Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation
- •Luminal diameter reduction of 50-100% by visual estimation
- •Severe calcification of the target lesion (for definition see appendix)
排除标准
- •Clinical exclusion criteria
- •Myocardial infarction (within 1 week)
- •Decompensated heart failure
- •Limited long term prognosis due to other conditions
- •Angiographic exclusion criteria
- •Target lesion is in a coronary artery bypass graft
- •Target lesion is an in-stent restenosis
- •Target vessel thrombus
结局指标
主要结局
Primary endpoint: Numerical in-stent acute lumen gain in mm
时间窗: At the end of the index procedure
The main angiographic endpoint will be in-stent acute lumen gain defined as minimal lumen diameter (MLD) in stent at the end of the index procedure minus baseline MLD.
Co-primary OCT endpoint: Ratio of stent expansion index (SEI)
时间窗: At the end of the index procedure
The main OCT endpoint will be stent expansion index (SEI), defined as minimum stent area divided by mean reference area in optical coherence tomography (OCT) quantitative analysis at the end of the index procedure
次要结局
- Numerical in-stent late lumen loss at 9 month follow-up angiography in mm(9 months follow-up)
- Rate of angiographic success in percent(Peri-procedural)
- Rate of in-segment binary restenosis at 9 months in percent(9 months follow-up)
- Rate of strategy success in percent(Peri-procedural)
- Rate of target vessel failure in percent(9 months, 1 and 2 years follow-up)
- Rate of peri-procedural myocardial infarction in percent(Peri-procedural)
- Numerical procedural duration in min(Peri-procedural)
- Numerical contrast dye amount in ml(Peri-procedural)
- Rate of stent thrombosis in percent(9 months, 1 and 2 years follow-up and final 5 years follow-up)
- Rate of vessel perforation in percent(Peri-procedural)