Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-05 @ 6:28 AM
Study NCT ID:
NCT03791320
Status:
COMPLETED
Last Update Posted:
2020-12-24
First Post:
2018-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fast Assessment of STenosis Severity- FASTII Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-23', 'studyFirstSubmitDate': '2018-12-20', 'studyFirstSubmitQcDate': '2018-12-29', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by corelab', 'timeFrame': '1 year', 'description': 'The diagnostic accuracy of offline vFFR assessed by a blinded independent core laboratory to identify hemodynamically-significant coronary stenosis with FFR (≤0.8 or \\>0.8) as the reference standard.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by site/operator', 'timeFrame': '1 year', 'description': 'The diagnostic accuracy of operator or cathlab technician calculated online vFFR to identify hemodynamically-significant coronary stenosis with FFR (≤0.8 or \\>0.8) as the reference standard.'}, {'measure': 'Interobserver variability', 'timeFrame': '1 year', 'description': '3D-QCA based FFR (vFFR) will be calculated twice: by the operator/technician of different centers AND by an independent corelab (Cardoalysis). Correlation and agreement between these two measurements will be assessed in order to investigate the Inter-observer variability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fractional Flow Reserve', 'Coronary Physiology', '3D-QCA', 'Percutaneous coronary intervention'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '34647890', 'type': 'DERIVED', 'citation': 'Masdjedi K, Tanaka N, Van Belle E, Porouchani S, Linke A, Woitek FJ, Bartorelli AL, Ali ZA, den Dekker WK, Wilschut J, Diletti R, Zijlstra F, Boersma E, Van Mieghem NM, Spitzer E, Daemen J. Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study. EuroIntervention. 2022 Apr 22;17(18):1498-1505. doi: 10.4244/EIJ-D-21-00471.'}]}, 'descriptionModule': {'briefSummary': 'The Multicenter FAST (Fast Assessment of STenosis severity) study is a prospective observational multicenter study designed to evaluate the diagnostic accuracy of offline 3D-QCA based FFR, using CAAS Workstation (Pie Medical Imaging, Maastricht, the Netherlands) in identifying hemodynamically significant coronary artery disease with pressure wire-based FFR (≤0.80) as the reference standard.', 'detailedDescription': 'The Multicenter FAST study is a prospective observational multicenter international study in which offline computation of vFFR is compared to conventional invasive, wire based FFR measurements. Pressure wire based FFR will be performed in patients with at least one intermediate coronary lesion at the discretion of the operator (typically defined as a coronary artery lesion with a diameter stenosis of 30-70% by visual assessment). A total of 3 two-dimensional angiography images, will be recorded and exported to the CAAS workstation 8.0 (Pie Medical Imaging, Maastricht, the Netherlands): two orthogonal views to create a 3D reconstruction of the coronary arteries and one view to ascertain the position of the FFR pressure wire. vFFR will be calculated automatically, by using the invasively measured aortic root pressure. vFFR measurements will be performed online by the different centers. In addition, all angiographic imaging data will be sent to an independent core laboratory (Cardialysis, Rotterdam, The Netherlands) for offline analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients ≥ 18 years presenting with stable or unstable angina or non-ST elevation acute coronary syndrome.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients ≥ 18 years\n* indication procedure: stable, unstable angina or non-ST elevation acute coronary syndrome\n* Diagnostic coronary angiography or PCI with an indication to perform re-PCI FFR assessment of at least one coronary artery lesion.\n\nExclusion Criteria:\n\n* ST-elevation myocardial infarction (STEMI)\n* Cardiogenic shock\n* Severe hemodynamic instability\n* Adenosine intolerance\n* Lesions containing thrombus, left main lesions, grafts, arteries with collaterals'}, 'identificationModule': {'nctId': 'NCT03791320', 'acronym': 'FASTII', 'briefTitle': 'Fast Assessment of STenosis Severity- FASTII Study', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Multicenter Validation of 3D-QCA Based FFR vs. Pressure Wire Based FFR: The FAST-II Study', 'orgStudyIdInfo': {'id': 'FASTII Study: June 26, 2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vessel Fractional Flow Reserve', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['3D-QCA based FFR'], 'description': 'FFR measurement based on coronary angiography'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10027', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Herzzentrum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical University', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Joost Daemen, MD;PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data are needed for the final analysis which will be done by Erasmus MC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tokyo Medical University', 'class': 'OTHER'}, {'name': 'Centro Cardiologico Monzino', 'class': 'OTHER'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'University Hospital Carl Gustav Carus', 'class': 'OTHER'}, {'name': 'University Hospital, Lille', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joost Daemen', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}