Intravascular Ultrasound Guidance for Complex High-Risk Indicated Procedures - IVUS-CHIP

European Cardiovascular Research Institute0 个研究点目标入组 620 人开始时间: 待定最近更新: 2024年8月26日

适应症

试验速览

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•1. The patient must be >=18 years of age
•2. Patients with an indication for PCI of at least one lesion satisfying any of
•the following criteria:
•a. Angiographic heavy calcification
•b. Ostial lesions
•c. True bifurcation lesions involving side-branches >2.5mm
•d. Left main lesions
•e. Chronic total occlusion
•f. In-stent restenosis
•g. Long-lesions (estimated stent length > 28mm)
•Patient with an indication for PCI for any lesion and in need for elective
•mechanical circulatory support assisted PCI
•3. Presenting with silent ischemia, stable angina, unstable angina or recent
•non-ST-elevation acute coronary syndrome (NSTE-ACS)
•4. All lesions must be suitable for treatment with the Synergy stent system,
•Synergy Megatron system, or other Synergy platform iteration
•5. The patient is willing and able to cooperate with study procedures and
•follow-up until study completion
•6. 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

•1. ST-elevation myocardial infarction, cardiogenic shock
•2. Known untreated severe valvular heart disease
•3. Known contraindication or hypersensitivity to everolimus, platinum-chromium,
•or to anticoagulants
•4. Absolute contraindications or allergy that cannot be pre-medicated, to
•iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12
•5. Non-cardiac co-morbidities with a life expectancy less than 1 year
•6. 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 for at least 12 months after enrollment and may only be
•enrolled once in the study
•7. Women of childbearing potential who do not have a negative pregnancy test
•within 7 days before the procedure and women who are breastfeeding
•8. Subject belongs to a vulnerable population (per investigator*s judgment) or
•subject unable to read or write

发起方

European Cardiovascular Research Institute