Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:47 AM
Study NCT ID:
NCT07308860
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-30
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Extended
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-26', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2025-12-26', 'lastUpdatePostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Major adverse cardiac events', 'timeFrame': '10 year follow-up', 'description': 'Additionally, we will compare individual rates of secondary clinical outcomes including myocardial infarction (MI), stroke, and repeat revascularization and combinations of the above, including death and MI, and death, MI, or stroke at 10-year follow-up after PCI or CABG.'}], 'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '10-year follow-up', 'description': 'The primary outcome is mortality or overall survival'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '10-year follow-up', 'description': 'Secondary aims include assessing quality of life at 10 years in the two groups utilizing the EQ-5D quality of life questionnaire.'}, {'measure': 'Angina Relief', 'timeFrame': '10 year follow-up', 'description': 'Secondary aims include assessing angina status at 10 years in the two groups utilizing the Seattle Angina Questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '40174598', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/40174598/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Coronary artery disease (CAD) remains the major cause of morbidity and mortality in adults in the United States. In patients with 3-vessel CAD not involving the left main coronary artery, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) can improve outcomes. Older studies have shown that the more invasive option, CABG, significantly reduces mortality during long-term follow-up compared with PCI. However, these studies did not use contemporary methods to perform PCI, such as measuring an index called fractional flow reserve (FFR) with a coronary pressure wire or using current- generation drug-eluting stents (DES), both of which significantly improve outcomes after PCI. The Fractional flow reserve versus Angiography for Multivessel Evaluation (FAME) 3 trial randomized 1,500 patients to FFR-guided PCI with current generation DES or to CABG and found that at 5 years there was no significant difference in the composite of death, myocardial infarction (MI) or stroke between the two strategies. There was a reduction in MI in the CABG group. Longer-term follow-up is critical to determine if contemporary PCI results in similar survival as CABG. The primary aim of this project is to determine if 10-year mortality is different after FFR-guided PCI compared with CABG. Investigators will perform 10-year follow-up in the 1,500 patients randomized in the FAME 3 trial to determine if FFR-guided PCI is non-inferior to CABG with respect to mortality. Secondary aims include assessing quality of life and angina relief at 10 years in the two groups. Additionally, investigators will compare individual rates of secondary clinical outcomes including MI, stroke, and repeat revascularization at 10-year follow-up after PCI or CABG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 21 years with angina and/or evidence of myocardial ischemia\n2. 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\n\n ≥50% stenosis\n3. Willing and able to provide informed, written consent\n\nExclusion Criteria:\n\n1. 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\n2. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support\n3. Recent STEMI (\\<5 days prior to randomization)\n4. Ongoing Non STEMI with biomarkers (cardiac troponin) still rising\n5. Known left ventricular ejection fraction \\<30%\n6. Life expectancy \\< 2 years\n7. Requiring renal replacement therapy\n8. Undergoing evaluation for organ transplantation\n9. Participation or planned participation in another clinical trial, except for observational registries\n10. Pregnancy\n11. Inability to take dual antiplatelet therapy or anticoagulation and single antiplatelet therapy for at least six months\n12. Previous CABG\n13. Left main disease requiring revascularization\n14. Extremely calcified or tortuous vessels precluding FFR measurement\n15. Any target lesion with in-stent drug-eluting stent restenosis\n16. More than one major epicardial vessel which is chronically occluded'}, 'identificationModule': {'nctId': 'NCT07308860', 'briefTitle': 'Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Extended', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '83374'}, 'secondaryIdInfos': [{'id': '1R01HL179196-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL179196-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'FFR-guided PCI group', 'description': 'These patients have undergone fractional flow reserve-guided percutaneous coronary intervention', 'interventionNames': ['Procedure: FFR-guided PCI']}, {'label': 'CABG group', 'description': 'These patients underwent coronary artery bypass grafting surgery', 'interventionNames': ['Procedure: CABG']}], 'interventions': [{'name': 'FFR-guided PCI', 'type': 'PROCEDURE', 'description': 'Coronary stenting compared with coronary bypass surgery', 'armGroupLabels': ['FFR-guided PCI group']}, {'name': 'CABG', 'type': 'PROCEDURE', 'description': 'Coronary artery bypass surgery', 'armGroupLabels': ['CABG group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor of Medicine', 'investigatorFullName': 'William Fearon', 'investigatorAffiliation': 'Stanford University'}}}}