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

NCT07557238 | Not Yet Recruiting DMC

• 1 other identifier: 2026-3151
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; High Risk PCI; Percutaneous Coronary Intervention (PCI)

Keywords

CHIP; complex high-risk PCI; Percutaneous Coronary Intervention; Coronary Artery Disease; left ventricular dysfunction; mechanical circulatory support; clinical outcomes; real-world registry

Outcome Measures

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.

  1 year after PCI

Secondary Outcomes (8)

• Major Adverse Cardiovascular Events at 1 Year After PCI

  1 year after PCI

• Cardiac death at 1 year after PCI

  1 year after PCI

• Myocardial Infarction at 1 Year After PCI

  1 year after PCI

• Target Vessel Revascularization at 1 Year After PCI

  1 year after PCI

• Hospitalization for Heart Failure at 1 Year After PCI

  1 year after PCI

Study Arms (1)

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; Device: Mechanical Circulatory Support

Interventions

Percutaneous Coronary Intervention PROCEDURE

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

CHIP-PCI Registry Cohort

Mechanical Circulatory Support DEVICE

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

CHIP-PCI Registry Cohort

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Guofeng Gao: lead
• Shenzhen Core Medical Technology CO.,LTD.: collaborator

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100037, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Ventricular Dysfunction, Left

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Guofeng Gao, MD

CONTACT

+86-13811458815; ggf03@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)