The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC): A Prospective Randomized Controlled Trial of Rotational Atherectomy Versus Cutting/Scoring Balloon in Severely Calcified Coronary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Strategy Success
研究概览
简要总结
The primary objective of this study is to evaluate the success of lesion preparation with either rotational atherectomy or cutting/scoring balloons as well as the long term effects of a hybrid sirolimus-eluting stent in an angiographically well-defined group of patients with complex calcified coronary lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •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
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
Strategy Success
时间窗: Intraprocedural
The primary endpoint will be 'Strategy Success' defined as successful stent delivery and expansion with attainment of \< 20% in-stent residual stenosis of the target lesion in the presence of TIMI 3 flow without crossover or stent failure
In-Stent late lumen loss at 9 months
时间窗: 9 months
Co-primary Endpoint: The in-stent late lumen loss at 9 months, defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD) and the in-stent MLD at 9-month followup angiography.
次要结局
- In-segment binary restenosis at 9 months(9 months)
- Amount of contrast dye(Intraprocedural)
- Target vessel failure (TVF)(9 months, 1 year, 2 years)
- Stent thrombosis at 9 months, 1 and 2 years(9 months, 1 and 2 years)
- Peri-procedural MI(within 72 hrs)
- Procedural duration(Intraproedural)
- In-segment late lumen loss at 9 months(9 months)