Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-20 @ 8:28 AM
Study NCT ID:
NCT03052803
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2017-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'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': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-24', 'studyFirstSubmitDate': '2017-02-10', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simultaneous FFR measure SJM and ACIST', 'timeFrame': 'Immediately', 'description': 'Correlation between simultaneous measures with St Jude medical FFR device and ACIST device'}, {'measure': 'Simultaneous FFR measure Boston Scientific and ACIST', 'timeFrame': 'Immediately', 'description': 'Correlation between simultaneous measures with BOSTON Scientific FFR device and ACIST device'}, {'measure': 'Simultaneous FFR measure Boston Scientific and SJM', 'timeFrame': 'Immediately', 'description': 'Correlation between simultaneous measures with BOSTON Scientific FFR device and St Jude Medical device'}], 'secondaryOutcomes': [{'measure': 'FFR SJM or Boston alone versus simultaneous with ACIST', 'timeFrame': 'Immediately', 'description': 'Correlation between SJM and Boston Scientific FFR measurements alone and simultaneous measure with ACIST'}, {'measure': 'Clinical concordance', 'timeFrame': 'Immediately', 'description': 'Concordance between FFR values \\>0.80 or \\<=0.80'}, {'measure': 'Drift of the signal', 'timeFrame': 'immediately', 'description': 'variation between the initial measure in the aorta (equalization) and final measure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['coronary stenosis', 'fractional flow reserve'], 'conditions': ['Coronary Artery Disease', 'Coronary Stenosis', 'Myocardial Ischemia']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.', 'detailedDescription': 'The decision to perform a percutaneous coronary intervention (PCI) is usually based on angiographic results alone. Angiography can be used for the visual evaluation of the inner diameter of a vessel. Visual evaluation is limited by inter-individual variability.\n\nFractional flow reserve provides a functional evaluation, by measuring the pressure decline caused by a vessel narrowing.\n\nThe original studies validating the use of FFR were conducted with only one device (St-Jude Medical®). Recently, new FFR devices have been commercialized but have not yet been compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutifs patients hospitalized for coronary angiography and presenting one or several coronary stenosis needing FFR evaluation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized at Caen University Hospital for coronary angiography\n* Coronary stenosis needing FFR evaluation according to recommendations\n* More than 18 years old\n* Clinically stable\n* De novo coronary stenosis\n* Affiliated to social security\n* Informed consent signed\n\nExclusion Criteria:\n\n* Unstable patients defined by acute coronary syndrome \\< 7 days\n* Contre-indication to adenosine administration (asthma, allergy, high grade atrio-ventricular bloc without pace maker)\n* History of coronary artery bypass\n* intra-stent restenosis\n* Patient not capable of understanding the study\n* Informed consent not signed'}, 'identificationModule': {'nctId': 'NCT03052803', 'acronym': 'FFR-DS', 'briefTitle': 'Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries : FRACTIONAL FLOW RESERVE - DEVICE STUDY (FFR-DS)', 'orgStudyIdInfo': {'id': '16-145'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fractional flow reserve measure', 'type': 'DEVICE', 'description': 'Comparison of different devices measuring fractional flow reserve'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'country': 'France', 'facility': 'CAEN University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Acist Medical Systems', 'class': 'INDUSTRY'}, {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}