About this trial
This is a prospective, multicenter, observational registry designed to evaluate clinical outcomes in patients undergoing complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) in China. Eligible patients will be adults with complex coronary artery disease and severely reduced left ventricular function, or reduced left ventricular function with severe mitral regurgitation, who are considered by the heart team to have an indication for coronary revascularization but are at high risk for coronary artery bypass grafting or decline surgical revascularization.
The registry will collect baseline clinical characteristics, coronary angiographic and procedural data, use of intravascular imaging or physiological assessment, revascularization strategy, mechanical circulatory support, peri-procedural complications, laboratory and echocardiographic data, and follow-up outcomes. The primary endpoint is all-cause mortality at 1 year after PCI. Secondary endpoints include major adverse cardiovascular events, cardiac death, myocardial infarction, target vessel revascularization, heart failure hospitalization, major bleeding, and quality-of-life measures. The study also aims to identify prognostic factors and develop a risk prediction model for patients undergoing CHIP-PCI.
Eligibility criteria
Qualifiers
Age 18 to 90 years.
Willing and able to comply with the study protocol and data collection procedures, able to understand the purpose of the study, and willing to provide written informed consent.
Considered by the heart team to have an indication for coronary revascularization but to be at high risk for coronary artery bypass grafting, or the patient declines coronary artery bypass grafting, and PCI is considered potentially beneficial after heart team evaluation.
Left ventricular ejection fraction ≤35%, or left ventricular ejection fraction ≤40% with severe mitral regurgitation.
Disqualifiers
Acute ST-segment elevation myocardial infarction within 1 week before enrollment.
Systolic arterial blood pressure <90 mmHg for ≥30 minutes, or need for vasopressors, inotropes, or mechanical circulatory support to maintain systolic arterial blood pressure ≥90 mmHg;
Evidence of reduced cardiac output, such as cardiac index <2.2 L/min/m²;
Evidence of end-organ hypoperfusion, including cold extremities, urine output <30 mL/hour, altered mental status, or lactate >2 mmol/L.
Trial design
Treatments tested in this trial
- Percutaneous Coronary Intervention
- Mechanical Circulatory Support
Treatment groups
Sponsors and collaborators
Guofeng Gao
Lead sponsor
China National Center for Cardiovascular Diseases
Sponsor institution
Shenzhen Core Medical Technology CO.,LTD.
Collaborator