Super High-Pressure Balloon Versus Intravascular Lithotripsy for Severely Calcified Coronary Lesions: The ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions (ISAR-CALC) 2 Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 9
- 主要终点
- Final angiographic minimal lumen diameter
研究概览
简要总结
The ISAR-CALC 2 trial is an investigator-initiated, prospective, randomized, multicenter, assessors-blind, open-label other clinical investigation. The objective of this trial is to investigate final angiographic minimal lumen diameter (MLD) following a strategy of super high-pressure balloon (OPN NC) versus intravascular lithotripsy (IVL) for drug-eluting stent (DES) implantation in severely calcified coronary lesions.
详细描述
Detailed information is provided elsewhere.
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
- •Age above 18 years and able to give consent
- •Persistent angina despite medical therapy and/or evidence of inducible ischemia
- •De-novo lesion in a native coronary artery
- •Target reference vessel diameter or intended stent diameter ≥2.50 or ≤4.00 mm by visual estimation
- •Severe calcification of the target lesion as determined by visual estimation at coronary angiography
- •Unsuccessful lesion preparation with standard non-compliant balloon (< 30% reduction of baseline diameter stenosis at maximal pressure)
- •Written informed consent.
排除标准
- •Target lesion is located in a coronary artery bypass graft
- •Target lesion is an in-stent restenosis
- •Target lesion is a chronic total occlusion
- •Target vessel thrombus
- •Limited long-term prognosis due to other comorbid conditions with life expectancy <12 months
研究组 & 干预措施
Super high-pressure balloon (OPN NC)
Patients will be treated with a Super High Pressure percutaneous transluminal coronary angioplasty (PTCA) Balloon (OPN NC).
干预措施: Super High Pressure Balloon (OPN NC) (Device)
Intravascular lithotripsy (IVL)
Patients will be treated with intravascular lithotripsy (IVL).
干预措施: Intravascular lithotripsy (IVL) (Device)
结局指标
主要结局
Final angiographic minimal lumen diameter
时间窗: Intraprocedural.
The primary outcome measure of the trial is the final angiographic minimal lumen diameter as assessed by angiographic core laboratory.
次要结局
- Angiographic Success(Intraprocedural.)
- Acute lumen gain(Intraprocedural.)
- Cost-effectiveness analysis(Intraprocedural.)
- Stent expansion as assessed by OCT imaging.(Intraprocedural.)
- Procedural Success(During index hospitalization, assessed up to 30 days.)
- Strategy Success(Intraprocedural.)
- Complementary lesion preparation(Intraprocedural.)
- MACE rates(30 days.)