Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,020
- 试验地点
- 37
- 主要终点
- Target-vessel failure comparison of IVUS-guided PCI to angio-guided PCI in patients with complex coronary lesions
研究概览
简要总结
The IVUS CHIP trial is a post-marketing strategy study in which patients with complex coronary lesions, undergoing percutaneous coronary intervention (PCI), are treated either with intravascular ultrasound (IVUS) guided PCI or angiographic guided PCI .
The IVUS-guided PCI approach is indicated to reduce the frequency of target-lesion failure (cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization) in patients with complex coronary lesions undergoing PCI.
The objective of this study is to assess the superiority of an IVUS-guided approach versus an angio-guided approach in patients with complex coronary lesions undergoing PCI.
详细描述
During percutaneous coronary intervention (PCI) coronary arteries are visualized to guide placing the stent. In this study 2 currently utilized methods of visualizing coronary arteries during PCI are compared: intravascular ultrasound (IVUS) and angiographic guided PCI for patients with complex coronary lesions. The use of IVUS during PCI is suggested to give better results than angiographic guided PCI.
The IVUS-CHIP trial is a randomized, controlled, multicenter, international, post-marketing study. A total of 2020 patients, in 7 European countries and approximately 40 hospitals, will be included, randomized in a 1:1 fashion to IVUS-guided PCI versus angio-guided PCI, and followed up for at least 2 years.
The IVUS-CHIP is an event-driven study; primary analysis of the data will take place after at least 169 patients have experienced an event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •All of the following:
- •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 the Synergy stent system, Synergy Megatron system, or other Synergy platform iteration
- •The patient is willing and able to cooperate with study procedures and follow-up until study 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
- •Any of the following:
- •ST-elevation myocardial infarction, cardiogenic shock
- •Known untreated severe valvular heart disease
- •IVUS is strictly required for pre-PCI lesion severity assessment
- •Requiring PCI in a diseased aorto-coronary bypass
- •Known contraindication or hypersensitivity to everolimus, platinum-chromium, or 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 another trial that is not yet at its primary endpoint. The patient is not allowed to participate in another investigational device or drug study until the trial primary endpoint time point is achieved and may only be enrolled once in the study
- •Women of childbearing potential who do not have a negative pregnancy test within 7 days before the procedure and women who are breastfeeding
- •Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write
研究组 & 干预措施
IVUS-guided PCI
Method is already used in standard care, but in this trial compared to another method also already used in standard care
干预措施: IVUS (Device)
Angio-guided PCI
Method is standard care
干预措施: Angio (Device)
结局指标
主要结局
Target-vessel failure comparison of IVUS-guided PCI to angio-guided PCI in patients with complex coronary lesions
时间窗: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Target-vessel failure is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization
次要结局
- Composite of cardiac death and target-vessel myocardial infarction(From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up)
- Composite of target-vessel myocardial infarction and clinically indicated target vessel revascularization(From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up)
- Clinically-indicated target vessel revascularization(From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up)
- Cardiac death(From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up)
- Target-Lesion Failure (TLF)(From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up)
- Target-lesion revascularization(From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up)