NCT07557238Not yet recruiting
CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China
A Prospective, Multicenter, Observational Registry to Evaluate Clinical Outcomes and Prognostic Factors in Patients Undergoing Complex High-Risk Indicated Percutaneous Coronary Intervention in China
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 23 Apr 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Guofeng Gao
- Diseases
- Coronary artery disease
- NCT number
- NCT07557238
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 1 Jun 2026 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute ST-segment elevation myocardial infarction within 1 week before enrollment.
Other illness
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the registry.
Lab values
- 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.
Other
- Participants meeting any of the following criteria will be excluded:
- Unable to complete the planned follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.