NCT07308860Active, not recruiting
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Extended
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Extended A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1500 (actual)
- First submitted
- 19 Dec 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- Stanford University
- Diseases
- Coronary artery disease, Stroke
- NCT number
- NCT07308860
What you commit to
- Study type: Observational
- Participants enrolled: 1500
- From 1 Aug 2025 to the primary completion date, 30 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent STEMI (\<5 days prior to randomization)
- Requiring renal replacement therapy
- Undergoing evaluation for organ transplantation
- Inability to take dual antiplatelet therapy or anticoagulation and single antiplatelet therapy for at least six months
- Previous CABG
- Any target lesion with in-stent drug-eluting stent restenosis
Other illness
- 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
- Ongoing Non STEMI with biomarkers (cardiac troponin) still rising
- Left main disease requiring revascularization
Lab values
- Known left ventricular ejection fraction \<30%
Age
- Life expectancy \< 2 years
Other
- Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
- Participation or planned participation in another clinical trial, except for observational registries
- Pregnancy
- Extremely calcified or tortuous vessels precluding FFR measurement
- More than one major epicardial vessel which is chronically occluded
Who the study is looking for
- 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
- ≥50% stenosis
- Willing and able to provide informed, written consent
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.