Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy: A Randomized, Multicenter Study About the Additional Benefit of Coronary Lithotripsy

Deutsches Herzzentrum Muenchen42 个研究点分布在 1 个国家目标入组 666 人2024年7月1日

适应症Coronary Artery Disease

干预措施Intravascular lithotripsy (IVL)Standard non-IVL methods

概览

阶段: 不适用
干预措施: Intravascular lithotripsy (IVL)
疾病 / 适应症: Coronary Artery Disease
发起方: Deutsches Herzzentrum Muenchen
入组人数: 666
试验地点: 42
主要终点: Combined endpoint of major cardiac and cerebrovascular events
状态: 招募中
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses.

注册库

clinicaltrials.gov

开始日期

2024年7月1日

结束日期

2027年7月31日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Deutsches Herzzentrum Muenchen

责任方

Sponsor

入排标准

入选标准

•age ≥18 years and able to give informed consent
•written informed consent to participate in the clinical trial
•typical angina pectoris or non-invasive evidence of relevant ischemia under optimal drug therapy
•angiographic evidence of coronary artery disease
•de novo lesion in a native coronary artery
•target vessel diameter 2.5-4 mm
•severe calcification of the target lesion (angiographic grade 3)

排除标准

•myocardial infarction \<1 week
•thrombus in the target vessel
•life expectancy due to other disease \<1 year
•simultaneous participation in a clinical trial with medical devices or medicinal products that has not yet been completed
•pregnancy (current, suspected, planned) or positive pregnancy test

研究组 & 干预措施

Lesion preparation using coronary intravascular lithotripsy

干预措施: Intravascular lithotripsy (IVL)

Lesion preparation using other methods than intravascular lithotripsy

e.g. cutting or super high pressure balloons and/or ablative procedures

干预措施: Standard non-IVL methods

结局指标

主要结局

Combined endpoint of major cardiac and cerebrovascular events

时间窗: 12 months after randomization

all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, clinically indicated revascularisation of the target vessel

次要结局

Non-fatal myocardial infarction(12 months after randomization)
Clinically indicated target vessel revascularization(12 months after randomization)
Definite stent thrombosis(12 months after randomization)
Clinically indicated non-target vessel revascularization(12 months after randomization)
Symptoms of CHD: mental health status(12 months after randomization)
Mortality(12 months after randomization)
Cardiac mortality(12 months after randomization)
Hospitalization due to acute coronary syndrome(12 months after randomization)
Procedural failure (failed application of study-related additional procedure, final TIMI flow <3, >30% residual stenosis, vessel perforation, stent loss, stent delivery failure)(12 months after randomization)
Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome)(12 months after randomization)
Non-fatal stroke(12 months after randomization)
Symptoms of coronary heart disease (CHD): physical health status(12 months after randomization)
Bleeding during index hospitalization or ≤30 days (BARC 3-5)(30 days after randomization)