Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 8:11 AM
Study NCT ID:
NCT03060460
Status:
TERMINATED
Last Update Posted:
2019-04-04
First Post:
2017-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'historical control cohort (Group A) and then a randomized prospective study (Group B and C).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': 'slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2017-02-18', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of puncture attempts', 'timeFrame': 'during the procedure', 'description': 'Number of attempts to puncture the vessel as evaluated by the physician and by go-pro camera recordings'}, {'measure': 'time of procedure', 'timeFrame': 'during the procedure', 'description': 'time from administration of analgetics to removal of the sheath'}, {'measure': 'Placement of sheath', 'timeFrame': 'during the procedure', 'description': 'Distance from proc.styloideus radius (radial procedure) or proximal part of caput femoris (femoral procedure) to vessel puncture site evaluated by angiography'}, {'measure': 'Pain during sheath insertion and during the procedure', 'timeFrame': 'during the procedure', 'description': 'Pain according to numerical rating scale during sheath insertion and during the procedure'}, {'measure': 'Successfull procedure', 'timeFrame': 'during the procedure', 'description': 'Proportion of patients where the procedure is completed according to prespecified access route (no conversion to femoral access if radial planned, and no conversion to radial access if femoral planned)'}], 'secondaryOutcomes': [{'measure': 'Use of analgetics', 'timeFrame': 'during the procedure', 'description': 'Cummulated dose of analgetics during the procedure'}, {'measure': 'Use of sedatives', 'timeFrame': 'during the procedure', 'description': 'Cummulated dose of sedatives during the procedure'}, {'measure': 'Use of calcium blocker', 'timeFrame': 'during the procedure', 'description': 'Cummulated dose of calcium blocker during the procedure'}, {'measure': 'Radial artery patency', 'timeFrame': 'during the procedure', 'description': 'Patency according to reverse Barbeau test at time of sheath removal'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radial', 'Angioplasty', 'Angiography', 'Ultrasound', 'Randomized']}, 'descriptionModule': {'briefSummary': 'The study evaluates whether routine use of ultrasound for sheath insertion during radial or femoral angiography or angioplasty has any impact on: number of punctures, patient discomfort, procedural length, successfull procedure or ideal vessel puncture.', 'detailedDescription': 'A randomised study with an historical control group.\n\nInitially data on prespecified endpoints are collected for an historical control group of 200 patients (100 radial and 100 femoral procedures). Hereafter 400 patients are randomized to ultrasound guided or conventional sheath insertion (200 radial and 200 femoral procedures).\n\nOnly high-volume physicians who have passed a ultrasound course are allowed to include patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients scheduled for angiography or angioplasty in whom both radial and femoral access is possible\n\nExclusion Criteria:\n\n* Abnormal pulse oxymetry test\n* If severe lower-extremity calcification is known to exclude femoral access'}, 'identificationModule': {'nctId': 'NCT03060460', 'acronym': 'ACCESS-II', 'briefTitle': 'Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital Skejby'}, 'officialTitle': 'Randomized Evaluation of Traditional Versus Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty', 'orgStudyIdInfo': {'id': 'ACCESS-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound arm - Randomized group', 'description': 'Ultrasound guided sheath insertion', 'interventionNames': ['Diagnostic Test: Ultrasound guided sheath insertion']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional arm - Randomized group', 'description': 'Conventional arm during randomized phase'}, {'type': 'NO_INTERVENTION', 'label': 'Historical control group', 'description': 'Conventional arm, non-randomization phase'}], 'interventions': [{'name': 'Ultrasound guided sheath insertion', 'type': 'DIAGNOSTIC_TEST', 'description': 'ultrasound is used routinely for sheath insertion', 'armGroupLabels': ['Ultrasound arm - Randomized group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of cardiology, Aarhus University Hospital in Skejby', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'erik sloth, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of anaestesiology, Aarhus University Hospital, DK-8200 Aarhus N'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymous data can be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christian Juhl Terkelsen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Christian Juhl Terkelsen', 'investigatorAffiliation': 'Aarhus University Hospital Skejby'}}}}