What is Fractional Flow Reserve (FFR) studying for Left Main Coronary Artery Disease?

This trial is comparing two methods to guide PCI treatment for Left Main Coronary Artery Disease by assessing which approach better affects major heart event risks over two years. Led by Seung-Jung Park, researchers aim to improve decision-making in treating this serious heart condition.

Who may be eligible for this Left Main Coronary Artery Disease clinical trial?

Adults aged 20 years or older with angina or signs of reduced heart blood flow may be eligible. Participants must have significant disease in the left main coronary artery suitable for PCI. People with prior left main PCI, coronary bypass surgery, or certain heart or kidney conditions are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this Left Main Coronary Artery Disease clinical trial?

Study-related care, including the study procedures and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 20Years +

All Genders

ID05829889

Comparing Fractional Flow Reserve and Angiography-Guided PCI for Treating Left Main Coronary Artery Disease

Led by Seung-Jung Park · Updated on 2026-06-24

960

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether the risk of major adverse cardiac events over two years differs between two methods of guiding Percutaneous Coronary Intervention PCI in patients with Left Main Coronary Artery LMCA disease. The study compares Fractional Flow Reserve FFR-guided PCI and angiography-guided PCI to understand which approach may better influence treatment decisions and outcomes for this condition. Participants will be randomly assigned to receive either FFR-guided PCI or angiography-guided PCI. Both procedures involve using drug-eluting stents to treat significant LMCA disease and may include patients with other coronary artery diseases. The study will monitor participants for two years after their procedure, capturing various heart-related events and treatment outcomes during this period. During the two-year follow-up, participants will have clinical visits and assessments to track events such as death, heart attacks, hospitalizations, repeat procedures, stroke, bleeding, and stent problems. Researchers will also evaluate hospital stay length, procedure details, heart function, quality of life related to angina and health, and medication use. The study aims to provide comprehensive information on the safety and effectiveness of both PCI guidance strategies over this time frame.

CONDITIONS

Brief Title

Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease

Who Can Participate

Age: 20Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants must be 20 years of age or older with angina and/or evidence of myocardial ischemia.
Significant new left main coronary artery disease with 50% or more narrowing suitable for PCI with drug-eluting stent.
Patient or guardian agrees to study protocol, follow-up schedule, and provides written informed consent.

You will not qualify if you...

Chronic total occlusion in left anterior descending or left circumflex coronary arteries.
Extremely calcified or twisted vessels that prevent FFR measurement.
Complex coronary disease or other heart conditions making PCI unsuitable.
Recent ST elevation myocardial infarction within 7 days before randomization.
Cardiogenic shock or need for mechanical/pharmacologic heart support.
Severe left ventricular dysfunction with ejection fraction below 30%.
Need for other cardiac surgery such as valve replacement or aorta surgery.
Inability or contraindication to take aspirin or P2Y12 inhibitors.
Prior PCI of the left main trunk.
Prior coronary artery bypass graft surgery.
Need for additional surgery within one year.
End-stage kidney disease requiring dialysis.
Liver cirrhosis.
Pregnant or breastfeeding women.
Medical conditions with life expectancy under two years.
Participation in other drug or device studies not completed primary endpoint follow-up, except certain academic or observational study exceptions.

Research Team

Duk-woo Park, MD

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Comparing Fractional Flow Reserve and Angiography-Guided PCI for Treating Left Main Coronary Artery Disease

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria