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

Sponsor
Guofeng Gao
Study ID
NCT07557238
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease
  • High Risk PCI
  • Percutaneous Coronary Intervention (PCI)

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Percutaneous Coronary Intervention — PROCEDURE
    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.
  • Mechanical Circulatory Support — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Apr 29, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: CHIP-PCI Registry Cohort
    Patients with complex high-risk indicated coronary artery disease undergoing percutaneous coronary intervention as part of routine clinical practice. Eligible patients include adults with complex coronary anatomy and reduced left ventricular function 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. PCI strategy, use of intravascular imaging or physiological assessment, revascularization approach, 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.

Primary Outcome Measure

All-cause Mortality at 1 Year After PCI [ Time Frame: 1 year after PCI ]

Central Contacts

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