Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 12:54 AM
Study NCT ID:
NCT01943903
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2013-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smullen@heartflow.com', 'phone': '408-314-2335', 'title': 'VP, Clinical', 'organization': 'HeartFlow'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Clinical Outcomes at 1 Year', 'description': 'All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Non-invasive (Cohort 2) Usual Care', 'description': "(Cohort 2) Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly.", 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 6, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Non-invasive Cohort (Cohort 2) FFRCT', 'description': 'The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 13, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Invasive Cohort (Cohort 1) Usual Care', 'description': '(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.', 'otherNumAtRisk': 187, 'deathsNumAtRisk': 187, 'otherNumAffected': 137, 'seriousNumAtRisk': 187, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Invasive Cohort (Cohort 1) FFRCT', 'description': 'The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.', 'otherNumAtRisk': 193, 'deathsNumAtRisk': 193, 'otherNumAffected': 24, 'seriousNumAtRisk': 193, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Invasive catheterization without obstructive CAD', 'notes': 'CAD - coronary artery disease. Obstructive CAD determined as 20%-80% stenosis by core lab quantitative coronary angiography (at 90 days).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 100, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 104, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 187, 'numAffected': 137}, {'groupId': 'EG003', 'numAtRisk': 193, 'numEvents': 193, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'All-cause death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nonfatal MI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 193, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization with urgent revascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 193, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MACE or vascular complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 193, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Negative Invasive Coronary Angiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Planned Invasive Test Usual Care Strategy (Cohort 1B)', 'description': 'Cohort 1B consisted of subjects who were referred for ICA and were evaluated and treated according to standard practice.'}, {'id': 'OG001', 'title': 'Planned Invasive Test FFRCT Guided Strategy (Cohort 2B)', 'description': 'Cohort 2B also consisted of subjects who were referred for ICA, but instead had cCTA imaging, and then at the investigators discretion had FFRCT analysis performed.'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 Days from first test', 'description': 'The primary endpoint of the PLATFORM Study is 90 day (+30/-15 days) rate of coronary angiogram showing no stenosis \\> 50% in a vessel \\> 2.0 mm by Quantitative Coronary Angiography (QCA), or no invasively-measured FFR \\< 0.80 in a segment distal to a stenosis in a vessel \\> 2.0 mm by QCA between Cohort 1 and 2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ICA - Invasive coronary angiography. Independent core laboratories performed quantitative coronary angiography.'}, {'type': 'SECONDARY', 'title': 'Number of MACE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '193', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-invasive (Cohort 2) Usual Care', 'description': "(Cohort 2) Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly."}, {'id': 'OG001', 'title': 'Non-invasive Cohort (Cohort 2) FFRCT', 'description': 'The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.'}, {'id': 'OG002', 'title': 'Invasive Cohort (Cohort 1) Usual Care', 'description': '(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.'}, {'id': 'OG003', 'title': 'Invasive Cohort (Cohort 1) FFRCT', 'description': 'The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days from first test', 'description': '90 days (+30/-30 days) Cohort 1 and Cohort 2 Major Adverse Coronary Event (MACE) rates, defined as:\n\n1. All cause death\n2. Non-fatal MI\n3. Unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all subjects who were enrolled into the study. Safety was monitored throughout the study. The low number of MACE events made it impossible to analyze the powered secondary endpoint. None of the events were related to the FFRCT.'}, {'type': 'SECONDARY', 'title': 'Number of MACE or Vascular Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '193', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-invasive (Cohort 2) Usual Care', 'description': "(Cohort 2) Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly."}, {'id': 'OG001', 'title': 'Non-invasive Cohort (Cohort 2) FFRCT', 'description': 'The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.'}, {'id': 'OG002', 'title': 'Invasive Cohort (Cohort 1) Usual Care', 'description': '(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.'}, {'id': 'OG003', 'title': 'Invasive Cohort (Cohort 1) FFRCT', 'description': 'The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days from first test', 'description': '90 days (+30/-30 days) Major Adverse Coronary Event (MACE) rates, defined as: all cause death, non-fatal MI, unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization and vascular complications (related to any coronary testing or procedure).This secondary endpoint compared the rates of MACE and vascular events across all subjects in Cohort 1 vs Cohort 2, Cohort 1A vs Cohort 2A and Cohort 1B vs Cohort 2B. The rates of MACE and vascular events were calculated by dividing the number of subjects with MACE and vascular events by the total number of subjects assigned to each analysis population.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all subjects who were enrolled into the study. It is important to note that none of the adverse events reported throughout the study were related to FFRCT.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '193', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-invasive (Cohort 1A) Usual Care', 'description': 'Cohort 1A consisted of subjects presenting for their initial noninvasive test and were evaluated according to standard practice.'}, {'id': 'OG001', 'title': 'Non-invasive Cohort (Cohort 2A) FFRCT', 'description': 'Cohort 2A also consisted of subjects presenting for their initial noninvasive test, but their first noninvasive test was cCTA with FFRCT analysis.'}, {'id': 'OG002', 'title': 'Invasive Cohort (Cohort 1B) Usual Care', 'description': 'Cohort 1B consisted of subjects who were referred for ICA and were evaluated and treated according to standard practice.'}, {'id': 'OG003', 'title': 'Invasive Cohort (Cohort 2B) FFRCT', 'description': 'Cohort 2B also consisted of subjects who were referred for ICA, but instead had cCTA imaging, and then at the investigators discretion had FFRCT analysis performed.'}], 'classes': [{'title': 'ECG', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'Stress Echo', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Nuclear/Stress MPI/CMR', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'cCTA without FFRCT', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'cCTA with FFRCT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}, {'title': 'IVUS, OCT, or FFR', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'ICA', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}]}, {'title': 'PCI', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}, {'title': 'CABG', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days from first test', 'description': 'Comparison of Resource utilization between cohort 1 and cohort 2 at 90 days (+/- 30 days):\n\n1. Non-invasive diagnostic tests\n2. Invasive diagnostic tests\n3. Coronary revascularization procedures', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Medications Used by Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '193', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-invasive (Cohort 1A) Usual Care', 'description': 'Cohort 1A consisted of subjects presenting for their initial noninvasive test and were evaluated according to standard practice.'}, {'id': 'OG001', 'title': 'Non-invasive Cohort (Cohort 2A) FFRCT', 'description': 'Cohort 2A also consisted of subjects presenting for their initial noninvasive test, but their first noninvasive test was cCTA with FFRCT analysis.'}, {'id': 'OG002', 'title': 'Invasive Cohort (Cohort 1B) Usual Care', 'description': 'Cohort 1B consisted of subjects who were referred for ICA and were evaluated and treated according to standard practice.'}, {'id': 'OG003', 'title': 'Invasive Cohort (Cohort 2B) FFRCT', 'description': 'Cohort 2B also consisted of subjects who were referred for ICA, but instead had cCTA imaging, and then at the investigators discretion had FFRCT analysis performed.'}], 'classes': [{'title': 'Aspirin', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': 'Statin', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 90 days', 'description': 'Comparison of medication use between cohort 1A, 1B and cohort 2A, 2B at 90 days (+/- 15 days)', 'unitOfMeasure': 'participants (total count)', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are the total number of patients who used particular medication (multiple medication types might be used per each patient)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-invasive (Cohort 2) Usual Care', 'description': "(Cohort 2) Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly."}, {'id': 'FG001', 'title': 'Non-invasive Cohort (Cohort 2) FFRCT', 'description': 'The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.'}, {'id': 'FG002', 'title': 'Invasive Cohort (Cohort 1) Usual Care', 'description': '(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.'}, {'id': 'FG003', 'title': 'Invasive Cohort (Cohort 1) FFRCT', 'description': 'The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '104'}, {'groupId': 'FG002', 'numSubjects': '187'}, {'groupId': 'FG003', 'numSubjects': '193'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '104'}, {'groupId': 'FG002', 'numSubjects': '187'}, {'groupId': 'FG003', 'numSubjects': '193'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of each subject considered for percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG), the investigator and the institution's heart team will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice.", 'preAssignmentDetails': 'Patients were eligible for enrollment if they were symptomatic, had an intermediate likelihood of CAD, did not have an established diagnosis of CAD, and were referred for clinically indicated testing to evaluate CAD. Patients referred for noninvasive testing were enrolled in a separate stratum than patients referred for invasive testing. The choice to refer the patient for invasive testing rather than noninvasive testing was made by the local clinicians before enrollment in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '584', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Invasive Cohort (Cohort 1) Usual Care', 'description': '(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.'}, {'id': 'BG001', 'title': 'Invasive Cohort (Cohort 1) FFRCT', 'description': 'The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.'}, {'id': 'BG002', 'title': 'Non-invasive (Cohort 2) Usual Care', 'description': "(Cohort 2) Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly."}, {'id': 'BG003', 'title': 'Non-invasive Cohort (Cohort 2) FFRCT', 'description': 'The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.36', 'spread': '10.93', 'groupId': 'BG000'}, {'value': '60.72', 'spread': '10.20', 'groupId': 'BG001'}, {'value': '57.91', 'spread': '10.72', 'groupId': 'BG002'}, {'value': '59.48', 'spread': '9.33', 'groupId': 'BG003'}, {'value': '60.86', 'spread': '10.54', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '231', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '353', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current smoker', 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '125', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '317', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hyperlipidemia', 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '203', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Atypical angina', 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '435', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior noninvasive testing', 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '197', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-test probability of CAD', 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '295', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 584}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2013-09-10', 'resultsFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2013-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-15', 'studyFirstPostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Negative Invasive Coronary Angiography', 'timeFrame': '90 Days from first test', 'description': 'The primary endpoint of the PLATFORM Study is 90 day (+30/-15 days) rate of coronary angiogram showing no stenosis \\> 50% in a vessel \\> 2.0 mm by Quantitative Coronary Angiography (QCA), or no invasively-measured FFR \\< 0.80 in a segment distal to a stenosis in a vessel \\> 2.0 mm by QCA between Cohort 1 and 2.'}], 'secondaryOutcomes': [{'measure': 'Number of MACE', 'timeFrame': '90 days from first test', 'description': '90 days (+30/-30 days) Cohort 1 and Cohort 2 Major Adverse Coronary Event (MACE) rates, defined as:\n\n1. All cause death\n2. Non-fatal MI\n3. Unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization'}, {'measure': 'Number of MACE or Vascular Complications', 'timeFrame': '90 days from first test', 'description': '90 days (+30/-30 days) Major Adverse Coronary Event (MACE) rates, defined as: all cause death, non-fatal MI, unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization and vascular complications (related to any coronary testing or procedure).This secondary endpoint compared the rates of MACE and vascular events across all subjects in Cohort 1 vs Cohort 2, Cohort 1A vs Cohort 2A and Cohort 1B vs Cohort 2B. The rates of MACE and vascular events were calculated by dividing the number of subjects with MACE and vascular events by the total number of subjects assigned to each analysis population.'}, {'measure': 'Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days', 'timeFrame': '90 days from first test', 'description': 'Comparison of Resource utilization between cohort 1 and cohort 2 at 90 days (+/- 30 days):\n\n1. Non-invasive diagnostic tests\n2. Invasive diagnostic tests\n3. Coronary revascularization procedures'}, {'measure': 'Number of Participants With Medications Used by Type', 'timeFrame': 'at 90 days', 'description': 'Comparison of medication use between cohort 1A, 1B and cohort 2A, 2B at 90 days (+/- 15 days)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '27470449', 'type': 'DERIVED', 'citation': 'Douglas PS, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Chiswell K, Cyr D, Wilk A, Wang F, Rogers C, Hlatky MA; PLATFORM Investigators. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study. J Am Coll Cardiol. 2016 Aug 2;68(5):435-445. doi: 10.1016/j.jacc.2016.05.057.'}, {'pmid': '26475205', 'type': 'DERIVED', 'citation': 'Hlatky MA, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Wilk A, Wang F, Rogers C, Douglas PS; PLATFORM Investigators. Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM. J Am Coll Cardiol. 2015 Dec 1;66(21):2315-2323. doi: 10.1016/j.jacc.2015.09.051. Epub 2015 Oct 14.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.jacc.2016.05.057', 'label': '1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study'}, {'url': 'https://doi.org/10.1016/j.jacc.2015.09.051', 'label': 'Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM'}]}, 'descriptionModule': {'briefSummary': 'The objective of the PLATFORM Study is to compare clinical outcomes, resource utilization, and quality of life (QOL) of FFRCT-guided evaluation versus standard practice evaluation in patients with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis of CAD', 'detailedDescription': 'The OVERALL OBJECTVE of this post-market, multicenter, longitudinal, prospective, consecutive cohort study is to compare clinical outcomes, resource utilization, and quality of life (QOL) in subjects receiving standard practice evaluation and treatment versus subjects receiving FFRCT-guided evaluation and treatment in subjects with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis of CAD. Cohort 1 of this study will assess outcomes incorporating standard practice evaluation and Cohort 2 will assess outcomes incorporating FFRCT-guided evaluation. Each Cohort will be further delineated based upon initial presentation, whereas subjects presenting for initial non-invasive testing will be designated as Cohorts 1A and 2A; and subjects already referred for ICA will be designated as Cohorts 1B and 2B.\n\nSPECIFIC OBJECTIVES for sequential cohort comparisons:\n\n1. To compare the rate of ICA documenting non-obstructive coronary artery disease, clinical outcomes, and QOL following standard practice for diagnostic and treatment planning modalities in Cohort 1 versus incorporating FFRCT as the preferred test to guide further invasive management and medical treatment in Cohort 2;\n2. To compare resource utilization following standard practice for diagnostic and treatment pathways in Cohort 1 versus incorporating FFRCT as the preferred test to guide further invasive management and medical treatment in Cohort 2;\n3. To provide supporting data for generating new guidelines for diagnosis and prognosis of CAD with comparative analysis of the risk stratification with the Updated Diamond-Forrester risk model (UDF);\n4. To provide society including patients, health care providers and other stakeholders with information about which diagnostic technologies are most effective and efficient in managing patients with CAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects referred with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Providing written informed consent\n* Subjects with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD who:\n* In Cohort 1A \\& 2A only are scheduled to undergo initial clinically-indicated non-invasive coronary evaluation, and have not undergone non-invasive coronary evaluation, including exercise tolerance testing, stress echocardiography, SPECT or MRI, or cCTA, within the past 90 days OR ICA at any time; or\n* In Cohort 1B \\& 2B only have been referred to invasive coronary angiography (ICA) and have not undergone ICA within the past 90 days\n* Ability to undergo cCTA\n\nExclusion Criteria:\n\n* Suspicion of acute coronary syndrome. Subjects experiencing unstable angina are not excluded where clinical documentation has ruled out a myocardial infarction.\n* Prior, clinically documented myocardial infarction\n* PCI prior to first test\n* CABG prior to first test\n* Contraindications for cCTA such as:\n* Presence of pacemaker or internal defibrillator leads\n* Atrial Fibrillation\n* Known anaphylactic allergy to iodinated contrast\n* Pregnancy or unknown pregnancy status in women of childbearing potential\n* Body mass index \\>35 kg/m2\n* Contraindication to acute beta blockade\n* Contraindication to acute sublingual nitrate administration\n* Prosthetic heart valve\n* Contraindications to FFRCT\n* Complex Congenital Heart disease other than anomalous coronary origins alone\n* Ventricular septal defect with known Qp/Qs\\>1.4\n* Requiring an emergent procedure within 48 hours of presentation\n* Evidence of active clinical instability, including cardiogenic shock, unstable blood pressure with systolic blood pressure \\<90 mmHg, or NYHA Grade III or IV congestive heart failure or acute pulmonary edema\n* Any active, serious, life-threatening disease with a life expectancy of less than 2 years\n* Inability to comply with study follow-up requirements\n* Current participation in any other clinical trial involving an investigational device or dictating care pathways at the time of enrollment.'}, 'identificationModule': {'nctId': 'NCT01943903', 'acronym': 'PLATFORM', 'briefTitle': 'The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts)', 'organization': {'class': 'INDUSTRY', 'fullName': 'HeartFlow, Inc.'}, 'officialTitle': 'Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts', 'orgStudyIdInfo': {'id': 'CP-903-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1 - Standard of Care', 'description': "Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of each subject considered for percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG), the investigator and the institution's heart team will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice. Cohort 1 of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD. Subjects will be followed for one year after enrollment."}, {'label': 'Cohort 2 - FFRCT-guided', 'description': "Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly. FFRCT is a non-invasive method to evaluate the hemodynamic significance of coronary artery lesions. FFRCT calculates FFR from subject-specific cCTA data using computational fluid dynamics under rest and simulated maximal coronary hyperemic conditions. FFRCT values range between 0 and 1, and values ≤0.80 are considered hemodynamically (HD)-significant."}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'HeartFlow, Inc', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Clinical Research Institution', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': 'A-8020', 'city': 'Graz', 'country': 'Austria', 'facility': 'LKH-GRAZ-West - Department of Cardiology', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'A-6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Innsbruck Medical University, Department of Radiology II', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'Cardiovascular Center Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital Skejby', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHU Brest - Hopital de Cardiologie', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '69677', 'city': 'Lyon', 'country': 'France', 'facility': 'Cardiovascular Hospital -Interventional Cardiology Dept, Hospices Civils de Lyon and Claude Bernard University France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Heart Center Leipzig GmbH', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitätsmedizin der Johannes Gutenberg-Universität Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '80636', 'city': 'Munich', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München - ISAResearch Centre', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '20154', 'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Freeman Hospital - Therapeutics & Cardiac Research Team', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Gianluca Pontone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Cardiologico Monzino'}, {'name': 'Pamela Douglas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Bernard de Bruyne, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Center Aalst'}, {'name': 'Mark Hlatky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HeartFlow, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Duke Clinical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}