Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-27 @ 12:52 AM
Study NCT ID:
NCT05982366
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2023-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of the Routine Distal Transradial Approach
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, single-center, randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2023-06-21', 'studyFirstSubmitQcDate': '2023-08-01', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Access-time', 'timeFrame': 'during procedure', 'description': 'counted from local anesthesia to successful insertion of the sheath'}, {'measure': 'radial artery size', 'timeFrame': 'before the procedure, 24 hours and 60 days after the procedure', 'description': 'parameter measured by Doppler Ultrasound at the access point'}, {'measure': 'radial artery velocity', 'timeFrame': 'before the procedure, 24 hours and 60 days after the procedure', 'description': 'parameter measured by Doppler Ultrasound at the access point'}], 'primaryOutcomes': [{'measure': 'The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.', 'timeFrame': 'up to 24 hours', 'description': 'Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.\n\nAccess-related complications after the procedure measured with Doppler Ultrasound (included radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm).\n\nMACE definied as myocardial infarction, stroke, urgent revascularization, all-cause death.'}], 'secondaryOutcomes': [{'measure': 'efficacy endpoint: rate of access crossover', 'timeFrame': 'during the procedure index', 'description': 'Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.'}, {'measure': "safety endpoint: patients' discomfort evaluated during access performance", 'timeFrame': 'during the procedure', 'description': 'physical discomfort at the time of vascular access performance was assessed using a numerical scale (0/1/2/3 - respectively no/mild/moderate/severe discomfort)'}, {'measure': 'efficacy endpoint: duration of access performance', 'timeFrame': 'during the procedure index', 'description': '(measured from the time of skin puncture with local anesthetic to the successful sheath insertion confirmed by an outflow of arterial blood)'}, {'measure': 'safety endpoint: access-site vascular complications', 'timeFrame': 'after 24 hours post procedure', 'description': 'it is composed by the rate of radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm; measured with Doppler Ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radial artery', 'distal transradial approach', 'access complication', 'anatomical snuffbox'], 'conditions': ['Vascular Access Complication', 'Radial Artery', 'Coronary Artery Disease', 'Puncture', 'Coronary Angiography']}, 'descriptionModule': {'briefSummary': 'The distal transradial approach (dTRA) via the anatomical snuffbox is hypothesized to be more beneficial than the conventional transradial access (cTRA) in patients undergoing coronary procedures. This prospective single-center randomized trial was designed to investigate the safety, efficacy, and various ultrasound parameters of dTRA.', 'detailedDescription': "Transradial approach (TRA) has emerged in most countries as a default strategy in urgent and elective coronary procedures. The advantages of TRA compared to the transfemoral access encompass a reduction of mortality, complications, and cost as well as improvement of patient's comfort. The aim of the present study (ANTARES, distAl vs coNventional Transradial Access for coRonary procEdures Study) was to assess the feasibility, safety and various ultrasound parameters of dTRA in the anatomical snuffbox as the first-line strategy, in comparison with cTRA, in patients undergoing coronary angiography (CAG) and percutaneous coronary intervention (PCI). The study is a non-inferiority, randomized controlled trial. There are two arms: distal transradial access and conventional transradial approach.\n\n400 patients were enrolled."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients referred for CAG and/or PCI\n\nExclusion Criteria:\n\n* ST-elevation myocardial infarction\n* sudden cardiac arrest\n* hemody-namic instability\n* chronic kidney disease (stages 4-5)\n* forearm artery occlusion\n* previous unsuccessful ipsilateral TRA\n* unfavorable RA diameter\n* ultrasound unavailability'}, 'identificationModule': {'nctId': 'NCT05982366', 'acronym': 'ANTARES', 'briefTitle': 'Feasibility and Safety of the Routine Distal Transradial Approach', 'organization': {'class': 'OTHER', 'fullName': 'Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński'}, 'officialTitle': 'distAl vs. coNventional Transradial Access for coRonary procEdures Study (ANTARES)', 'orgStudyIdInfo': {'id': 'AntaresStudy01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Distal transradial approach', 'description': 'Distal transradial approach as the default strategy', 'interventionNames': ['Other: distal radial artery acess side']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional transradial approach', 'description': 'Conventional transradial approach as the default strategy', 'interventionNames': ['Other: conventional radial artery acess side']}], 'interventions': [{'name': 'distal radial artery acess side', 'type': 'OTHER', 'otherNames': ['dTRA'], 'description': 'coronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area', 'armGroupLabels': ['Distal transradial approach']}, {'name': 'conventional radial artery acess side', 'type': 'OTHER', 'otherNames': ['cTRA'], 'description': 'coronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area', 'armGroupLabels': ['Conventional transradial approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89-600', 'city': 'Chojnice', 'state': 'Pomeranian', 'country': 'Poland', 'facility': 'Szpital Specjalistyczny', 'geoPoint': {'lat': 53.69554, 'lon': 17.55701}}], 'overallOfficials': [{'name': 'Łukasz Koziński, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Indywidualna Praltyka Lekarska Lekarz Łukasz Koziński'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Łukasz Koziński', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Łukasz Koziński, Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński', 'investigatorFullName': 'Łukasz Koziński', 'investigatorAffiliation': 'Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński'}}}}