NCT06274645招募中不适用
Intravascular Ultrasound Guidance for Complex High-Risk Indicated Procedures China Registry
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 2,020 人开始时间: 2024年3月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,020
- 试验地点
- 1
- 主要终点
- Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints.
研究概览
简要总结
The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question[s] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The patient must be ≥18 years of age
- •Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:
- •Angiographic heavy calcification
- •Ostial lesions
- •True bifurcation lesions involving side-branches >2.5mm
- •Left main lesions
- •Chronic total occlusion
- •In-stent restenosis
- •Long-lesions (estimated stent length > 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI
- •Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
- •All lesions must be suitable for treatment with 2nd generation drug eluting stents (or drug-coated balloons when indicated, e.g., in-stent restenosis, branching of bifurcation lesions)
- •The patient is willing and able to cooperate with registry procedures and follow-up until registry completion
- •Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee
排除标准
- •ST-elevation myocardial infarction or cardiogenic shock within prior 7 days
- •Known untreated severe valvular heart disease
- •Requiring PCI in a diseased aorto-coronary bypass
- •Known contraindication or hypersensitivity to anticoagulants
- •Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
- •Non-cardiac co-morbidities with a life expectancy less than 1 year
- •Currently participating in a clinical trial that is not yet at its primary endpoint. The patient is not allowed to participate in an investigational device or drug study until the trial primary endpoint time point is achieved and may only be enrolled once in the study
- •Women who are pregnant or who are breastfeeding
- •Subject's circumstances that will not allow appropriate consenting procedures or follow-up activities (per investigator's discretion)
结局指标
主要结局
Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints.
时间窗: 1 Year
Target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction\*, or clinically indicated target-vessel revascularization at 1 year. It means the time of the patient's occurrence of any of the three events in one year.
次要结局
- Time-to-first-event analysis will be primarily used for clinical endpoints.(full-time process until 2 Year)
研究者
研究点 (1)
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