New study to track survival in High-Risk heart procedures
NCT ID NCT07557238
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037, China
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Other studies related to the condition(s) this trial covers.
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- Hospital-to-Home transitional cardiac rehabilitation as a transition from Centre-Based cardiac rehabilitation after cardiac surgery: a Single-Blind randomised controlled trial
- Opportunistic screening of coronary artery calcium on Non-Gated routine chest CT using artificial intelligence: retrospective external validation and clinical risk stratification
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