NCT06369142招募中不适用
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 人开始时间: 2024年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 666
- 试验地点
- 42
- 主要终点
- Combined endpoint of major cardiac and cerebrovascular events
研究概览
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.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The study participant as well as the follow-up physicians and site personal are blinded.
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 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
Experimental
干预措施: Intravascular lithotripsy (IVL) (Device)
Lesion preparation using other methods than intravascular lithotripsy
Active Comparator
e.g. cutting or super high pressure balloons and/or ablative procedures
干预措施: Standard non-IVL methods (Device)
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)
研究者
研究点 (42)
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