New study to track survival in High-Risk heart procedures

NCT ID NCT07557238

Knowledge-focused Sponsor: Guofeng Gao Source: ClinicalTrials.gov ↗

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The trial has finished. Results may not be published yet.
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow 1000 adults in China with severe coronary artery disease who are too high-risk for bypass surgery and need complex angioplasty. Researchers will collect data on their health, procedures, and outcomes for one year to see what factors affect survival and complications. The goal is to better understand risks and improve future care for these patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Ventricular Dysfunction, Left

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Beijing, 100037, China

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