An observational study in Coronary Artery Disease, High Risk PCI and Percutaneous Coronary Intervention (PCI), sponsored by Guofeng Gao. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Guofeng Gao · Observational
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.
Complex high-risk indicated patients undergoing percutaneous coronary intervention represent a clinically challenging population. These patients often have complex coronary anatomy, impaired cardiac function, hemodynamic vulnerability, advanced age, frailty, or multiple comorbidities. Although advances in interventional techniques, adjunctive devices, intravascular imaging, physiological assessment, and mechanical circulatory support have expanded the feasibility of PCI in this population, evidence regarding optimal treatment strategies and long-term outcomes remains limited, particularly in real-world Chinese practice.
This study is a prospective, multicenter, observational registry conducted in tertiary hospitals with experience in complex high-risk PCI. The study will enroll approximately 1,000 patients who meet the predefined eligibility criteria and undergo PCI as part of routine clinical care. No additional interventional treatment will be mandated by the protocol. PCI strategy, use of intravascular imaging such as IVUS or OCT, physiological assessment such as FFR or QFR, lesion preparation techniques, complete or incomplete revascularization, staged PCI, antithrombotic therapy, and the use and type of mechanical circulatory support will be determined by the treating physicians according to contemporary guidelines, expert consensus, and local clinical practice.
Eligible patients include adults aged 18 to 90 years 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 CABG, and for whom PCI is considered beneficial. Patients are required to have left ventricular ejection fraction ≤35%, or left ventricular ejection fraction ≤40% with severe mitral regurgitation, together with complex PCI features such as unprotected left main disease, last remaining patent coronary artery PCI, three-vessel disease, heavily calcified lesions requiring rotational atherectomy, or chronic total occlusion requiring bilateral angiography or retrograde techniques. Patients with acute ST-segment elevation myocardial infarction within 1 week, cardiogenic shock, inability to complete follow-up, or other conditions considered unsuitable by investigators will be excluded.
Data collection will include demographic characteristics, medical history, comorbidities, medication use, cardiac function, physical examination, laboratory tests, electrocardiography, echocardiography, quality-of-life assessments, coronary angiography, lesion characteristics, procedural details, use of intravascular imaging or physiological assessment, lesion preparation, mechanical circulatory support, procedural success, completeness of revascularization, residual SYNTAX score, and peri-procedural complications. Follow-up will be performed at 1 month, 3 months, 6 months, 1 year, and 2 years after PCI by outpatient visit or telephone contact. Quality-of-life assessments will be collected at 3 months, 6 months, 1 year, and 2 years. Clinical events suggestive of cardiovascular outcomes, including chest pain, myocardial infarction, heart failure, or other cardiovascular hospitalization, will be recorded and adjudicated according to predefined endpoint definitions.
The primary endpoint is all-cause mortality at 1 year after PCI. Secondary endpoints include 1-year major adverse cardiovascular events, defined as a composite of all-cause death, myocardial infarction, target vessel revascularization, and heart failure hospitalization; cardiac death; myocardial infarction; target vessel revascularization; heart failure hospitalization; major bleeding defined as BARC type 3 or 5 bleeding; and quality-of-life scores. Additional analyses will evaluate the association between clinical, anatomical, procedural, imaging, physiological, and mechanical circulatory support variables and clinical outcomes. The registry will also be used to develop a risk prediction model to support clinical decision-making in patients undergoing CHIP-PCI.
This registry is expected to provide real-world evidence on contemporary CHIP-PCI practice in China, including patient characteristics, procedural strategies, use of adjunctive technologies, short- and long-term outcomes, and predictors of adverse events. The findings may help optimize risk stratification, procedural planning, and post-PCI management in complex high-risk patients.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →This is the only study on the registry with Guofeng Gao as lead sponsor.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
Undergoing complex PCI with at least one of the following features:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
Cardiogenic shock, defined by all of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Percutaneous Coronary Intervention · Device: Mechanical Circulatory Support
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.
Also known as: PCI
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.
Also known as: MCS
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 PCI
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 PCI
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 PCI
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 PCI
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 PCI
Hospitalization for Heart Failure at 1 Year After PCI
The proportion of participants hospitalized for worsening heart failure within 1 year after PCI. Heart failure hospitalization is defined as hospitalization lasting at least 24 hours due to worsening heart failure symptoms, with a documented diagnosis of heart failure and initiation or intensification of heart failure therapy.
Time frame: 1 year after PCI
Major Bleeding at 1 Year After PCI
The proportion of participants who experience major bleeding within 1 year after PCI. Major bleeding is defined as Bleeding Academic Research Consortium type 3 or type 5 bleeding.
Time frame: 1 year after PCI
Change in Health-Related Quality of Life Assessed by EQ-5D-5L
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire. Scores will be collected at baseline and during follow-up to evaluate changes after PCI.
Time frame: Baseline, 3 months, 6 months, 1 year, and 2 years after PCI
Change in Angina-Related Quality of Life Assessed by the Seattle Angina Questionnaire
Angina-related symptoms, functional status, and quality of life will be assessed using the Seattle Angina Questionnaire. Scores will be collected at baseline and during follow-up to evaluate changes after PCI.
Time frame: Baseline, 3 months, 6 months, 1 year, and 2 years after PCI
Plan to share: No
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