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

NCT07308860 | Active Not Recruiting DMC

• 2 other identifiers: 833741R01HL179196-01
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

CABG; FFR-guided PCI; quality of life; repeat revascularization; long term mortality; 3-vessel CAD; angina; 10-year mortality; stroke; cardiac death; stent; PCI; myocardial infarction; multicenter; coronary artery bypass; clinical trial; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Survival

  The primary outcome is mortality or overall survival

  10-year follow-up

Secondary Outcomes (2)

• Quality of life

  10-year follow-up

• Angina Relief

  10 year follow-up

Other Outcomes (1)

• Major adverse cardiac events

  10 year follow-up

Study Arms (2)

FFR-guided PCI group

These patients have undergone fractional flow reserve-guided percutaneous coronary intervention

Procedure: FFR-guided PCI

CABG group

These patients underwent coronary artery bypass grafting surgery

Procedure: CABG

Interventions

FFR-guided PCI PROCEDURE

Coronary stenting compared with coronary bypass surgery

FFR-guided PCI group

CABG PROCEDURE

Coronary artery bypass surgery

CABG group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Participation or planned participation in another clinical trial, except for observational registries
• Pregnancy
• Inability to take dual antiplatelet therapy or anticoagulation and single antiplatelet therapy for at least six months
• Previous CABG
• Left main disease requiring revascularization
• Extremely calcified or tortuous vessels precluding FFR measurement
• Any target lesion with in-stent drug-eluting stent restenosis

Sponsors & Collaborators

• Stanford University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• Fearon WF, Zimmermann FM, Ding VY, Takahashi K, Piroth Z, van Straten AHM, Szekely L, Davidavicius G, Kalinauskas G, Mansour S, Kharbanda R, Ostlund-Papadogeorgos N, Aminian A, Oldroyd KG, Al-Attar N, Jagic N, Dambrink JE, Kala P, Angeras O, MacCarthy P, Wendler O, Casselman F, Witt N, Mavromatis K, Miner SES, Sarma J, Engstrom T, Christiansen EH, Tonino PAL, Reardon MJ, Otsuki H, Kobayashi Y, Hlatky MA, Mahaffey KW, Desai M, Woo YJ, Yeung AC, Pijls NHJ, De Bruyne B. Outcomes after fractional flow reserve-guided percutaneous coronary intervention versus coronary artery bypass grafting (FAME 3): 5-year follow-up of a multicentre, open-label, randomised trial. Lancet. 2025 Apr 26;405(10488):1481-1490. doi: 10.1016/S0140-6736(25)00505-7. Epub 2025 Mar 30.

  PMID: 40174598 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Stroke; Death; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Infarction; Ischemia; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor of Medicine

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: December 30, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: December 30, 2025

Record last verified: 2025-08

Locations

US (1)