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

NCT07557238 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Shenzhen Core Medical Technology CO.,LTD.

    collaborator INDUSTRY

  • Guofeng Gao

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07557238 on ClinicalTrials.gov