Comparison of Coronary Lithoplasty and Rotablation for the Interventional Treatment of Severely Calcified Coronary Stenoses - ROTA.Shock-Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Minimal Stent Area (End of the Procedure)
研究概览
简要总结
This study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation.
详细描述
Severe coronary calcification is still a challenge for percutaneous coronary intervention (PCI). Reduction of the calcified plaque mass is necessary to achieve adequate stent expansion during further course. Rotablation has been the only reliable option to treat extremely calcified coronary lesions for a long time. Coronary lithoplasty has been recently introduced as a new promising treatment option in this special subset. It provides the unique opportunity to break severely calcified plaque structures even inside deeper layers of the vessel wall. Aim of this study is to compare rotablation and coronary lithotripsy for treatment of severely calcified coronary lesions. Plaque structure, plaque volume, as well as lumen diameters will be analyzed by optical coherence tomography (OCT) before and after debulking, as well as after stent implantation.
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
- Single (Outcomes Assessor)
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>18 yrs
- •Stable coronary heart disease or acute coronary syndromes
- •Single or multi vessel disease. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
- •Written informed consent was obtained before the procedure
- •Severely calcified coronary lesion with indication for rotablation
排除标准
- •Known renal insufficiency (serum creatinine clearance <30ml/min/1.73m² or receiving dialysis)
- •Known allergy against protocol-required medications including ASS, prasugrel, ticagrelor, clopidogrel, heparin. History of bleeding diathesis or known coagulopathy
- •Cardiogenic shock
- •Lesion length > 32mm
- •Bifurcation lesions requiring 2-Stent-Strategies
研究组 & 干预措施
Rotablation
干预措施: Rotablation (Procedure)
Coronary Lithoplasty
干预措施: Coronary Lithoplasty (Procedure)
结局指标
主要结局
Minimal Stent Area (End of the Procedure)
时间窗: 0 days
次要结局
- Minimal/Mean/Maximal Stent Diameter(0 days)
- Minimal/Mean/Maximal Lumen diameter(0 days)
- Incidence of target vessel failure(0 months; 1 month; 6 months)
- Incidence of target lesion failure(0 months; 1 month; 6 months)
- MACE rate(0 months; 1 month; 6 months)
- Minimal/Mean/Maximal Lumen area(0 days)
- Mean/Maximal Stent area(0 days)