CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorGuofeng Gao
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Acute ST-segment elevation myocardial infarction within 1 week before enrollment.
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.
Trial population
The study population will consist of adult patients with complex high-risk indicated coronary artery disease undergoing percutaneous coronary intervention in routine clinical practice at participating tertiary hospitals in China. Eligible patients will have complex coronary anatomy and impaired left ventricular function, and will be considered by the heart team to have an indication for coronary revascularization but to be at high risk for coronary artery bypass grafting or to have declined surgical revascularization. PCI strategy, adjunctive imaging or physiological assessment, revascularization approach, antithrombotic therapy, and use of mechanical circulatory support will be determined by the treating physicians according to clinical judgment and local practice. This is an observational registry and no study-mandated intervention will be assigned.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Percutaneous Coronary Intervention
Procedure/SurgeryPercutaneous 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
DeviceMechanical 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.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: CHIP-PCI Registry Cohort2 interventions
Trial outcomes
Primary outcomes
1
All-cause Mortality at 1 Year After PCI
The proportion of participants who die from any cause within 1 year after percutaneous coronary intervention.
Time frame
1 year after PCISecondary outcomes
1
Major Adverse Cardiovascular Events at 1 Year After PCI
The proportion of participants who experience a major adverse cardiovascular event within 1 year after PCI. Major adverse cardiovascular events are defined as a composite of all-cause death, myocardial infarction, target vessel revascularization, or hospitalization for heart failure.
Time frame
1 year after PCI2
Cardiac death at 1 year after PCI
The proportion of participants who die from cardiac causes within 1 year after PCI. Cardiac death includes death due to acute myocardial infarction, heart failure, cardiogenic shock, pulmonary edema, cardiac perforation or tamponade, arrhythmia or conduction disturbance, procedure-related cerebrovascular events within 30 days, procedure-related complications, or death in which a cardiac cause cannot be excluded.
Time frame
1 year after PCI3
Myocardial Infarction at 1 Year After PCI
The proportion of participants who experience myocardial infarction within 1 year after PCI, including peri-procedural myocardial infarction and spontaneous myocardial infarction according to predefined study criteria.
Time frame
1 year after PCI4
Target Vessel Revascularization at 1 Year After PCI
The proportion of participants who undergo repeat revascularization of the target vessel within 1 year after PCI.
Time frame
1 year after PCISponsors and contacts
Click on the lead sponsor to view all of their trials.
Guofeng Gao
Lead sponsor
China National Center for Cardiovascular Diseases
Sponsor institution
Shenzhen Core Medical Technology CO.,LTD.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: