CTRI/2025/09/095273尚未招募不适用
European Registry On Plaque ModifiCAtion in the STEMI Population (ROCA-STEMI)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Target Vessel Failure The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization
研究概览
简要总结
This is an European prospective cohort study from February 2023 until February 2026 The investigators want to analyze the clinical success, efficacy and safety of consecutive patients who presented with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention for de novo heavily calcified culprit lesion using plaque modification devices before stent implantation
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of STEMI Undergoing primary PCI De novo culprit lesion in a native coronary artery Severe calcification of the target lesion or equivalent balloon uncrossable or undilatable lesion Use of a plaque modification device to treat the culprit lesion Signed written informed consent by the patient or their legal representative.
排除标准
- •The target vessel had a stent from a previous PCI The target lesion was treated as a staged procedure Pregnant women Terminally ill patients.
结局指标
主要结局
Target Vessel Failure The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization
时间窗: 12 Months
次要结局
- Cardiac death Death that could not be attributed to a noncardiac etiology was considered cardiac death
研究者
Dr Sarita Rao
Department of Cardiology 5th floor Apollo Rajshree Hospitals Sector-D Scheme No 74C Vijay Nagar Indore Madhya Pradesh 452010
研究点 (1)
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