Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-02 @ 4:23 AM
Study NCT ID:
NCT01132495
Status:
COMPLETED
Last Update Posted:
2019-09-16
First Post:
2010-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000787', 'term': 'Angina Pectoris'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmifek@sjm.com', 'phone': '651-756-5586', 'title': 'Sr. Director, Global Clinical Affairs', 'organization': 'St. Jude Medical'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.', 'description': 'Only Serious Adverse Events were collected in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A - PCI Plus OMT', 'description': 'PCI plus optimal medical treatment\n\nStenting plus OMT: FFR guided PCI, plus OMT', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 447, 'seriousNumAffected': 137}, {'id': 'EG001', 'title': 'Cohort A - OMT Alone', 'description': 'Optimal medical treatment alone\n\nStandard of care: OMT alone', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 441, 'seriousNumAffected': 324}, {'id': 'EG002', 'title': 'Cohort B - Follow-up', 'description': 'Observation with treatment based on physician preference', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 166, 'seriousNumAffected': 55}, {'id': 'EG003', 'title': 'Cohort B - No Follow-up Re-consented', 'description': 'Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 116, 'seriousNumAffected': 28}], 'seriousEvents': [{'term': 'Non Urgent Revacularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 441, 'numEvents': 162, 'numAffected': 144}, {'groupId': 'EG002', 'numAtRisk': 166, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 116, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death or MI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 48, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 441, 'numEvents': 65, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 166, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 116, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 441, 'numEvents': 48, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 166, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 116, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unplanned Hospitalization with Urgent Revascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 441, 'numEvents': 63, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 166, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 116, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 441, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 166, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 116, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 441, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 441, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Major Adverse Cardiac Event Rate (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '441', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - PCI Plus OMT', 'description': 'PCI plus optimal medical treatment - Stenting plus OMT: FFR guided PCI, plus OMT'}, {'id': 'OG001', 'title': 'Cohort A - OMT Alone', 'description': 'Optimal medical treatment alone - Standard of care: OMT alone'}], 'classes': [{'title': 'Non Urgent Revascularization', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '32.7', 'groupId': 'OG001'}]}]}, {'title': 'Death or Myocardial Infarction', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}]}]}, {'title': 'Myocardial Infarction', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Unplanned Hospitalizations with urgent revasc', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '13.4', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Cerebrovascular Event', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Other Serious Adverse Event (SAE)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Month', 'description': 'MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.', 'unitOfMeasure': 'percentage of subjects with SAEs', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary outcome analysis was designed for Cohort A only.'}, {'type': 'SECONDARY', 'title': 'Overall MACE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '441', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: PCI Plus OMT', 'description': 'Patient with at least one hemodynamically significant stenosis (FFR, ≤0.80)\n\nPCI plus optimal medical treatment\n\nStenting plus OMT: FFR guided PCI, plus OMT'}, {'id': 'OG001', 'title': 'Cohort A: OMT Alone', 'description': 'Patient with at least one hemodynamically significant stenosis (FFR, ≤0.80)\n\nOptimal medical treatment alone\n\nOMT: OMT alone'}, {'id': 'OG002', 'title': 'Cohort B: Registry Cohort', 'description': 'Patients in whom all stenoses had an FFR \\>0.80 were entered into a registry'}], 'classes': [{'title': 'Overall MACE', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '12.7', 'groupId': 'OG002'}]}]}, {'title': 'Death from any cause', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '3.0', 'groupId': 'OG002'}]}]}, {'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}, {'value': '6.6', 'groupId': 'OG002'}]}]}, {'title': 'Urgent revascularization', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '17.2', 'groupId': 'OG001'}, {'value': '6.6', 'groupId': 'OG002'}]}]}, {'title': 'Any revascularization', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '44.2', 'groupId': 'OG001'}, {'value': '14.5', 'groupId': 'OG002'}]}]}, {'title': 'Nonurgent revascularization', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '30.2', 'groupId': 'OG001'}, {'value': '9.0', 'groupId': 'OG002'}]}]}, {'title': 'Cardiac death', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Individual components of the primary end point, cardiac death, and nonurgent revascularization', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': "For registry cohort B, 50% of the patients with an FFR \\>0.80 across all lesions were followed up in a registry, and therefore, cohort B group for 'No Follow-up Re-consented' arm had no follow-up result and was not included in the endpoint analysis."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A - PCI Plus OMT', 'description': 'PCI plus optimal medical treatment\n\nStenting plus OMT: FFR guided PCI, plus OMT'}, {'id': 'FG001', 'title': 'Cohort A - OMT Alone', 'description': 'Optimal medical treatment alone\n\nStandard of care: OMT alone'}, {'id': 'FG002', 'title': 'Cohort B - Follow-up', 'description': 'Observation with treatment based on physician preference'}, {'id': 'FG003', 'title': 'Cohort B - No Follow-up Re-consented', 'description': 'Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '447'}, {'groupId': 'FG001', 'numSubjects': '441'}, {'groupId': 'FG002', 'numSubjects': '166'}, {'groupId': 'FG003', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '407'}, {'groupId': 'FG001', 'numSubjects': '403'}, {'groupId': 'FG002', 'numSubjects': '146'}, {'groupId': 'FG003', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Various reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '12'}]}]}], 'preAssignmentDetails': 'Participants were randomized to Cohort A if at least one stenoses had an FFR value of \\<=0.80. Participants with FFR \\>0.80 were treated according to local practice and were randomized to study follow-up / no study follow-up in Cohort B. Therefore, participants are either in cohort A or cohort B (not both).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'BG000'}, {'value': '441', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '1170', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A - PCI Plus OMT', 'description': 'PCI plus optimal medical treatment\n\nStenting plus OMT: FFR guided PCI, plus OMT'}, {'id': 'BG001', 'title': 'Cohort A - OMT Alone', 'description': 'Optimal medical treatment alone\n\nStandard of care: OMT alone'}, {'id': 'BG002', 'title': 'Cohort B - Follow-up', 'description': 'Observation with treatment based on physician preference'}, {'id': 'BG003', 'title': 'Cohort B - No Follow-up Re-consented', 'description': 'Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '64.4', 'spread': '8.8', 'groupId': 'BG003'}, {'value': '63.7', 'spread': '9.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '354', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': '884', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-08', 'studyFirstSubmitDate': '2010-05-20', 'resultsFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2010-05-27', 'lastUpdatePostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-13', 'studyFirstPostDateStruct': {'date': '2010-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Event Rate (MACE)', 'timeFrame': '24 Month', 'description': 'MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.'}], 'secondaryOutcomes': [{'measure': 'Overall MACE', 'timeFrame': '3 years', 'description': 'Individual components of the primary end point, cardiac death, and nonurgent revascularization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stable angina', 'angina pectoris', 'PCI', 'FAME', 'FAME II', 'FFR', 'Fractional Flow Reserve', 'Pressure wire'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '30354650', 'type': 'DERIVED', 'citation': 'Nishi T, Piroth Z, De Bruyne B, Jagic N, Mobius-Winkler S, Kobayashi Y, Derimay F, Fournier S, Barbato E, Tonino P, Juni P, Pijls NHJ, Fearon WF. Fractional Flow Reserve and Quality-of-Life Improvement After Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease. Circulation. 2018 Oct 23;138(17):1797-1804. doi: 10.1161/CIRCULATIONAHA.118.035263.'}, {'pmid': '29785878', 'type': 'DERIVED', 'citation': 'Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrom T, Kaab S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Frobert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbuhler M, Juni P, De Bruyne B; FAME 2 Investigators. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22.'}, {'pmid': '29162610', 'type': 'DERIVED', 'citation': 'Ciccarelli G, Barbato E, Toth GG, Gahl B, Xaplanteris P, Fournier S, Milkas A, Bartunek J, Vanderheyden M, Pijls N, Tonino P, Fearon WF, Juni P, De Bruyne B. Angiography Versus Hemodynamics to Predict the Natural History of Coronary Stenoses: Fractional Flow Reserve Versus Angiography in Multivessel Evaluation 2 Substudy. Circulation. 2018 Apr 3;137(14):1475-1485. doi: 10.1161/CIRCULATIONAHA.117.028782. Epub 2017 Nov 21.'}, {'pmid': '29097450', 'type': 'DERIVED', 'citation': 'Fearon WF, Nishi T, De Bruyne B, Boothroyd DB, Barbato E, Tonino P, Juni P, Pijls NHJ, Hlatky MA; FAME 2 Trial Investigators. Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation). Circulation. 2018 Jan 30;137(5):480-487. doi: 10.1161/CIRCULATIONAHA.117.031907. Epub 2017 Nov 2.'}, {'pmid': '27884241', 'type': 'DERIVED', 'citation': 'Barbato E, Toth GG, Johnson NP, Pijls NH, Fearon WF, Tonino PA, Curzen N, Piroth Z, Rioufol G, Juni P, De Bruyne B. A Prospective Natural History Study of Coronary Atherosclerosis Using Fractional Flow Reserve. J Am Coll Cardiol. 2016 Nov 29;68(21):2247-2255. doi: 10.1016/j.jacc.2016.08.055.'}, {'pmid': '25176289', 'type': 'DERIVED', 'citation': 'De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nuesch E, Juni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1.'}, {'pmid': '23946263', 'type': 'DERIVED', 'citation': 'Fearon WF, Shilane D, Pijls NH, Boothroyd DB, Tonino PA, Barbato E, Juni P, De Bruyne B, Hlatky MA; Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 2 (FAME 2) Investigators. Cost-effectiveness of percutaneous coronary intervention in patients with stable coronary artery disease and abnormal fractional flow reserve. Circulation. 2013 Sep 17;128(12):1335-40. doi: 10.1161/CIRCULATIONAHA.113.003059. Epub 2013 Aug 14.'}, {'pmid': '22924638', 'type': 'DERIVED', 'citation': 'De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.', 'detailedDescription': 'Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with\n\n * stable angina or,\n * stabilized angina pectoris or,\n * atypical chest pain or no chest pain but with documented silent ischemia\n2. at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium\n3. Eligible for PCI\n4. Signed written informed consent\n\nExclusion Criteria:\n\n1. Patients in whom the preferred treatment is CABG\n2. Patients with left main coronary artery disease requiring revascularization\n3. Patients with a recent STEMI or Non-STEMI\n4. Prior CABG\n5. Contra-indication to dual antiplatelet therapy\n6. LVEF \\< 30%\n7. Severe LV hypertrophy\n8. Planned need for concomitant cardiac surgery\n9. Extremely tortuous or calcified coronary arteries precluding FFR measurements\n10. A life expectancy of less than 2 years\n11. Age under 21'}, 'identificationModule': {'nctId': 'NCT01132495', 'briefTitle': 'FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease', 'orgStudyIdInfo': {'id': '0904'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cohort A: PCI plus OMT', 'description': 'PCI plus optimal medical treatment', 'interventionNames': ['Other: Stenting plus OMT']}, {'type': 'OTHER', 'label': 'Cohort A: OMT alone', 'description': 'Optimal medical treatment alone', 'interventionNames': ['Other: OMT']}, {'type': 'OTHER', 'label': 'Cohort B', 'description': 'FFR \\> 0.80; treatment according to local practice', 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