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NCT07557238

CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China

Sponsor: Guofeng Gao

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective, Multicenter, Observational Registry to Evaluate Clinical Outcomes and Prognostic Factors in Patients Undergoing Complex High-Risk Indicated Percutaneous Coronary Intervention in China

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-06-01

Completion Date

2029-12-31

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

PROCEDURE

Percutaneous Coronary Intervention

Percutaneous coronary intervention performed as part of routine clinical care in patients with complex high-risk indicated coronary artery disease. The procedural strategy, use of intravascular imaging or physiological assessment, lesion preparation, revascularization extent, staged PCI, antithrombotic therapy, and use of mechanical circulatory support are determined by the treating physicians according to clinical judgment and local practice. No study-mandated intervention is assigned.

DEVICE

Mechanical Circulatory Support

Mechanical circulatory support, including intra-aortic balloon pump, extracorporeal membrane oxygenation, Impella-like devices, or other support devices, may be used during high-risk PCI at the discretion of the treating physicians. Use of mechanical circulatory support is not mandated by the study protocol and will be analyzed as an observational exposure.

Locations (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China