Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-31 @ 4:54 PM
Study NCT ID:
NCT02480569
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2015-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Compare FFR Measurement With a Non-Side-Hole Guide Catheter Vs. a Side-Hole Guide Catheter
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-09', 'studyFirstSubmitDate': '2015-06-17', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FFR measurement using a guide catheter with and without side holes', 'timeFrame': 'Less than 1 hour during the coronary angiography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The investigators propose a single center prospective study that will assess two different strategies for measuring Fractional Flow Reserve (FFR) in patients undergoing clinically-indicated coronary angiography in whom FFR measurement is indicated. FFR will be measured with a non-side hole guide catheter (with the guide catheter both engaged and disengaged from the coronary ostium) and with a side-hole guide catheter (with the guide catheter both engaged and disengaged from the coronary ostium) to determine, whether measurements obtained with an engaged side-hole guide catheter are more accurate as compared with those obtained with the engaged non-side hole catheter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing a clinically indicated coronary catheterization\n* Need FFR of a coronary artery lesion\n* Agree to participate and able to provide informed consent\n\nExclusion Criteria:\n\n* Significant difficulty advancing the pressure measuring guidewire into the coronary artery\n* Severe chronic obstructive pulmonary disease\n* Severe ostial disease (\\>70% diameter stenosis within 5 mm from the coronary artery ostium)'}, 'identificationModule': {'nctId': 'NCT02480569', 'briefTitle': 'Trial to Compare FFR Measurement With a Non-Side-Hole Guide Catheter Vs. a Side-Hole Guide Catheter', 'organization': {'class': 'FED', 'fullName': 'North Texas Veterans Healthcare System'}, 'officialTitle': 'Trial to Compare FFR Measurement With a Non-Side-Hole Guide Catheter Vs. a Side-Hole Guide Catheter', 'orgStudyIdInfo': {'id': '15-033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Side-Hole Catheter', 'description': '2 FFR measurements from an engaged side-hole guide catheter and a disengaged side-hole guide catheter', 'interventionNames': ['Other: FFR Measurement']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Side-Hole Catheter', 'description': '2 FFR measurements from an engaged non-side-hole guide catheter and a disengaged non-side-hole guide catheter', 'interventionNames': ['Other: FFR Measurement']}], 'interventions': [{'name': 'FFR Measurement', 'type': 'OTHER', 'armGroupLabels': ['Non-Side-Hole Catheter', 'Side-Hole Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Texas Veterans Healthcare System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emmanouil S Brilakis, MD, PhD', 'investigatorFullName': 'Emmanouil Brilakis', 'investigatorAffiliation': 'North Texas Veterans Healthcare System'}}}}