Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT01233518
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2010-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
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': 'whuey@heartflow.com', 'phone': '650.257.6697', 'title': 'Whitney Huey', 'organization': 'Heartflow, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Single Arm Study', 'description': 'Patients will receive cCTA, ICA, FFR, and cFFR per protocol.\n\nFFR: Fractional flow reserve measured during cardiac catheterization', 'otherNumAtRisk': 252, 'otherNumAffected': 0, 'seriousNumAtRisk': 252, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Retroperitoneal bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Study', 'description': 'Per-patient performance (diagnostic accuracy) CCTA plus FFRCT'}], 'classes': [{'title': 'Accuracy of FFRCT', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '78'}]}]}, {'title': 'Accuracy of CCTA', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis\\* at the subject level using binary outcomes when compared to invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and FFRCT measurements were recorded on a continuous scale and dichotomized at the 0.80 threshold (values ≤0.80 considered diseased; values \\>0.80 nondiagnostic for ischemia). Stenosis on CCTA was recorded at the 50% threshold (stenoses ≥50% considered obstructive and \\<50% as non-significant). Prespecified primary endpoint was expected to be greater than 70% of the lower bound of the 95% confidence interval.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diagnostic Performance of CCTA Plus FFRCT at the Subject Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Study', 'description': 'Patients will receive cCTA, ICA, FFR, and cFFR per protocol.\n\nFFR: Fractional flow reserve measured during cardiac catheterization'}], 'classes': [{'title': 'Sensitivity', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '95'}]}]}, {'title': 'Specificity', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '83'}]}]}, {'title': 'Positive predictive value', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '74'}]}]}, {'title': 'Negative predictive value', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '90'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CCTA plus CT-FLOW at the subject level using binary outcomes when compared to FFR as the reference standard.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm Study', 'description': 'Patients will receive cCTA, ICA, FFR, and cFFR per protocol.\n\nFFR: Fractional flow reserve measured during cardiac catheterization'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '285'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '252'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm Study', 'description': 'Patients will receive cCTA, ICA, FFR, and cFFR per protocol.\n\nFFR: Fractional flow reserve measured during cardiac catheterization'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '135', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '117', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '178', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 285}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2010-10-13', 'resultsFirstSubmitDate': '2018-06-15', 'studyFirstSubmitQcDate': '2010-11-01', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-29', 'studyFirstPostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone', 'timeFrame': '1 day', 'description': 'Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis\\* at the subject level using binary outcomes when compared to invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and FFRCT measurements were recorded on a continuous scale and dichotomized at the 0.80 threshold (values ≤0.80 considered diseased; values \\>0.80 nondiagnostic for ischemia). Stenosis on CCTA was recorded at the 50% threshold (stenoses ≥50% considered obstructive and \\<50% as non-significant). Prespecified primary endpoint was expected to be greater than 70% of the lower bound of the 95% confidence interval.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic Performance of CCTA Plus FFRCT at the Subject Level', 'timeFrame': '1 day', 'description': 'Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CCTA plus CT-FLOW at the subject level using binary outcomes when compared to FFR as the reference standard.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CCTA Coronary Artery Disease CAD'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '21930103', 'type': 'BACKGROUND', 'citation': 'Min JK, Berman DS, Budoff MJ, Jaffer FA, Leipsic J, Leon MB, Mancini GB, Mauri L, Schwartz RS, Shaw LJ. Rationale and design of the DeFACTO (Determination of Fractional Flow Reserve by Anatomic Computed Tomographic AngiOgraphy) study. J Cardiovasc Comput Tomogr. 2011 Sep-Oct;5(5):301-9. doi: 10.1016/j.jcct.2011.08.003. Epub 2011 Aug 7.'}, {'pmid': '22922562', 'type': 'RESULT', 'citation': 'Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.'}, {'pmid': '25592691', 'type': 'DERIVED', 'citation': 'Park HB, Heo R, O Hartaigh B, Cho I, Gransar H, Nakazato R, Leipsic J, Mancini GBJ, Koo BK, Otake H, Budoff MJ, Berman DS, Erglis A, Chang HJ, Min JK. Atherosclerotic plaque characteristics by CT angiography identify coronary lesions that cause ischemia: a direct comparison to fractional flow reserve. JACC Cardiovasc Imaging. 2015 Jan;8(1):1-10. doi: 10.1016/j.jcmg.2014.11.002.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.', 'detailedDescription': '285 patient, prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Patients providing written informed consent\n* Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ICA)\n* Has undergone \\>64 multidetector row CCTA within 60 days prior to ICA\n* No cardiac interventional therapy between the CCTA and ICA\n\nExclusion Criteria:\n\n* Prior coronary artery bypass graft (CABG) surgery\n* Prior percutaneous coronary intervention (PCI) for which suspected coronary artery lesion(s) are within a stented coronary vessel\n* Contraindication to adenosine, including 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, severe asthma, , severe COPD or bronchodilator-dependent COPD\n* Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)\n* Recent prior myocardial infarction within 40 days of ICA\n* Known complex congenital heart disease\n* Prior pacemaker or internal defibrillator lead implantation\n* Prosthetic heart valve\n* Significant arrhythmia or tachycardia\n* Impaired chronic renal function (serum creatinine \\>1.5 mg/dl\n* Patients with known anaphylactic allergy to iodinated contrast\n* Pregnancy or unknown pregnancy status\n* Body mass index \\>35\n* Patient requires an emergent procedure\n* Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \\<90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema\n* Any active, serious, life-threatening disease with a life expectancy of less than 2 months\n* Inability to comply with study procedures'}, 'identificationModule': {'nctId': 'NCT01233518', 'acronym': 'DeFACTO', 'briefTitle': 'Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography', 'organization': {'class': 'INDUSTRY', 'fullName': 'HeartFlow, Inc.'}, 'officialTitle': 'Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography', 'orgStudyIdInfo': {'id': 'CP-901-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single arm study', 'description': 'Patients will receive cCTA, ICA, FFR, and cFFR per protocol.', 'interventionNames': ['Device: FFR']}], 'interventions': [{'name': 'FFR', 'type': 'DEVICE', 'description': 'Fractional flow reserve measured during cardiac catheterization', 'armGroupLabels': ['Single arm study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Spring Hill Hospital', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}], 'overallOfficials': [{'name': 'James K Min, MD, FACC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HeartFlow, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Baim Institute for Clinical Research', 'class': 'OTHER'}, {'name': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center', 'class': 'OTHER'}, {'name': 'Minneapolis Heart Institute Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}