Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-30 @ 8:00 PM
Study NCT ID:
NCT01559493
Status:
COMPLETED
Last Update Posted:
2012-03-21
First Post:
2012-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fractional Flow Reserve (FFR) Versus Instant Wave-Free Ratio (iFR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D058226', 'term': 'Plaque, Atherosclerotic'}], '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': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-19', 'studyFirstSubmitDate': '2012-02-14', 'studyFirstSubmitQcDate': '2012-03-19', 'lastUpdatePostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice', 'timeFrame': '30 days', 'description': 'In this prospective, multicenter, international investigation, all consecutive patients in 5 centers, referred for PCI will be included. FFR will be submitted for one vessel in each patient - this will be the first vessel in which the FFR is performed. Measurements will be performed in duplicate. iFR will be calculated for all lesions for which an FFR measurement is submitted. In addition, iFR and FFR will be compared retrospectively in 1000 patients who had FFR measurements in the recent past'}], 'secondaryOutcomes': [{'measure': 'iFR at rest vs iFr during hyperemia', 'timeFrame': '30 days', 'description': 'iFR is said to be independent of hyperemia. Accordingly a secondary outcome of this study will be a paired comparison of iFR at rest vs iFr with adenosine induced hyperemia.'}, {'measure': 'Repeatability of iFr and FFR', 'timeFrame': '30 days', 'description': 'To test repeatability of iFR and FFR'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atherosclerotic lesion assessment'], 'conditions': ['Coronary Artery Disease', 'Plaque, Atherosclerotic']}, 'referencesModule': {'references': [{'pmid': '23395076', 'type': 'DERIVED', 'citation': "Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6."}]}, 'descriptionModule': {'briefSummary': 'Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice\n\n* To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous coronary intervention (PCI).\n* To investigate the influence of hyperemia on iFR.\n* To test reproducibility of iFR and FFR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The aim of the present study is to strengthen the results of retrospective comparisons of iFR with FFR by conducting a prospective study in 200 consecutive, unselected patients from 5 different centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all consecutive patients undergoing FFR assessment for standard clinical indications.\n\nExclusion Criteria:\n\n* prior CABG\n* extremely tortuous, calcified lesions\n* coronary artery occlusion\n* acute MI within 5 days'}, 'identificationModule': {'nctId': 'NCT01559493', 'briefTitle': 'Fractional Flow Reserve (FFR) Versus Instant Wave-Free Ratio (iFR)', 'organization': {'class': 'OTHER', 'fullName': 'NHS National Waiting Times Centre Board'}, 'officialTitle': 'Comparison of Fractional Flow Reserve Versus Instant Wave-Free Ratio for Assessment of Coronary Artery Stenosis Severity in Routine Practice', 'orgStudyIdInfo': {'id': 'Version F 2nd Jan 2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FFR; iFR', 'description': 'Interventional Cardiology, Pressure wire, fractional flow reserve, coronary flow measurement'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'Cardiovascular Center Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'University Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Stockholm South Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Prof Keith G. Oldroyd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Golden Jubilee National Hospital'}, {'name': 'Prof Colin Berry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Golden Jubilee National Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS National Waiting Times Centre Board', 'class': 'OTHER'}, 'collaborators': [{'name': 'Golden Jubilee National Hospital', 'class': 'OTHER_GOV'}, {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, {'name': 'Onze Lieve Vrouw Hospital', 'class': 'OTHER'}, {'name': 'Stockholm South General Hospital', 'class': 'OTHER'}, {'name': 'Brno University Hospital', 'class': 'OTHER'}, {'name': 'Stanford University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Cardiologist', 'investigatorFullName': 'Prof. Keith G. Oldroyd', 'investigatorAffiliation': 'NHS National Waiting Times Centre Board'}}}}