CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China
Starting soon
Conditions studied: Coronary Artery Disease, High Risk PCI, Percutaneous Coronary Intervention (PCI)
In brief
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 facts
- Study ID
- NCT07557238
- Run by
- Guofeng Gao
- People needed
- 1000
- Starts
- 2026-06-01
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-05-12
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants must meet all of the following criteria:
- 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.
- Undergoing complex PCI with at least one of the following features:
- Unprotected left main coronary artery disease;
- PCI of the last remaining patent coronary artery;
- Three-vessel coronary artery disease;
- Calcified coronary lesion requiring rotational atherectomy;
- Chronic total occlusion requiring bilateral angiography or retrograde techniques.
You may not qualify if…
- Participants meeting any of the following criteria will be excluded:
- Acute ST-segment elevation myocardial infarction within 1 week before enrollment.
- Cardiogenic shock, defined by all of the following:
- 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.
- Unable to complete the planned follow-up.
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the registry.
Where it is running
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China
Full record on ClinicalTrials.gov
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