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

A Prospective, Multicenter, Observational Registry to Evaluate Clinical Outcomes and Prognostic Factors in Patients Undergoing Complex High-Risk Indicated Percutaneous Coronary Intervention in China

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention (PCI); High Risk PCI
• Intervention / Treatment: Procedure: Percutaneous Coronary Intervention; Device: Mechanical Circulatory Support

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Guofeng Gao, MD; Phone Number: +86-13811458815; Email: ggf03@163.com

Study Locations

• China
  • Beijing, China, 100037
    • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Contact: Guofeng Gao, MD; Phone Number: +86-13811458815; Email: ggf03@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

Participants must meet all of the following criteria:

1. Age 18 to 90 years.
2. 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.
3. 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.
4. Left ventricular ejection fraction ≤35%, or left ventricular ejection fraction ≤40% with severe mitral regurgitation.

5. 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.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded:

1. Acute ST-segment elevation myocardial infarction within 1 week before enrollment.

2. 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.
3. Unable to complete the planned follow-up.
4. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the registry.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Procedure: Percutaneous Coronary Intervention; 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.; Other Names: PCI; Device: Mechanical Circulatory Support; 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.; Other Names: MCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Mortality at 1 Year After PCI	The proportion of participants who die from any cause within 1 year after percutaneous coronary intervention.	1 year after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Baseline, 3 months, 6 months, 1 year, and 2 years after PCI

Collaborators and Investigators

• Sponsor: Guofeng Gao
• Collaborators: Shenzhen Core Medical Technology CO.,LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; clinical outcomes; left ventricular dysfunction; mechanical circulatory support; CHIP; real-world registry; complex high-risk PCI
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Ventricular Dysfunction; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Ventricular Dysfunction, Left; Coronary Artery Disease; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Percutaneous Coronary Intervention
• Other Study ID Numbers: 2026-3151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No