Active — Not RecruitingNot Applicable

Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Extended

United States1,500 participantsStarted 2025-08-01

Plain-language summary

Coronary artery disease, or narrowing of the blood vessels that provide blood to the heart, is the most common cause of death in the United States and can be treated with either coronary bypass surgery or coronary stent placement. This study will evaluate outcomes, including death and quality of life, at 10 years in 1,500 patients with coronary disease who have already been randomized to either bypass surgery or stenting.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Age ≥ 21 years with angina and/or evidence of myocardial ischemia
✓. Three vessel CAD, defined as ≥ 50% diameter stenosis by visual estimation in each of the three major epicardial vessels or major side branches, but not involving left main coronary artery, and amenable to revascularization by both PCI and CABG as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if only the left anterior descending artery (LAD) and left circumflex have
✓. Willing and able to provide informed, written consent

Exclusion criteria

✕. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, carotid revascularization), however a maze procedure or pulmonary vein isolation is allowed
✕. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
✕. Recent STEMI (\<5 days prior to randomization)
✕. Ongoing Non STEMI with biomarkers (cardiac troponin) still rising
✕. Known left ventricular ejection fraction \<30%
✕. Life expectancy \< 2 years
✕. Requiring renal replacement therapy
✕. Undergoing evaluation for organ transplantation

What they're measuring

Survival

Timeframe: 10-year follow-up

Trial details

NCT IDNCT07308860

SponsorStanford University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-06-30

View on ClinicalTrials.gov More Coronary Artery Disease trials