Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:02 AM
Study NCT ID:
NCT07399392
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2025-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radial Versus Femoral Secondary Access in Patients Undergoing TAVI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 434}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular and bleeding complications related to the secondary vascular access site', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Until 30 days after index procedure:', 'timeFrame': '30 days', 'description': '* cardiovascular mortality\n* non-cardiovascular mortality\n* mortality related to vascular and bleeding complications\n* Incidence of new neurological events after randomization\n* Vascular complications at 30 days\n* Bleeding complications at 30 days\n* Incidence of acute kidney injury'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TAVI(Transcatheter Aortic Valve Implantation)']}, 'descriptionModule': {'briefSummary': 'Severe symptomatic aortic stenosis (AS) with a high gradient is associated with a poor prognosis if not treated with valve replacement. Transcatheter aortic valve implantation has been shown in large randomized trials to be a safe and effective treatment option for patients at low, intermediate, or high risk. Transfemoral access for heart valve replacement is by far the most commonly used approach, as it is relatively easy to control and has a low complication rate compared to other access routes.\n\nThe TAVI procedure requires two arterial access points: one with a large lumen for the TAVI prosthesis via the femoral artery, and a smaller second one for a pigtail catheter that guides the TAVI prosthesis into the optimal position. This secondary access is most often via a second artery.\n\nVascular complications are the most commonly observed complications in transfemoral TAVI and are associated with poorer procedural outcomes.\n\nRecent data suggest that secondary vascular access via the radial artery may contribute to a reduction in vascular complications after TAVI. In patients undergoing coronary angiography and/or percutaneous coronary intervention, radial access has become the preferred strategy due to its proven reduction in vascular complications compared to femoral access. The use of radial access is associated with a lower incidence of vascular complications compared to femoral access.\n\nRecent non-randomized data suggest that radial access may be a safer alternative to traditional femoral access as a secondary arterial access in transfemoral TAVI. However, non-randomized retrospective comparisons are subject to selection bias and underreporting of complications. Therefore, a prospective randomized trial is needed to evaluate the value of radial access for secondary arterial access in patients undergoing transfemoral TAVI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for transfemoral TAVI\n* Heart team agrees on eligibility of TAVI\n* Written informed consent\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Non accessible radial arteries as judged by the TAVI team\n* Non accessible femoral arteries as judged by the TAVI team\n* Foreseeable problems to achieve primary transfemoral access (hostile access)\n* Hemodynamic instability or cardiogenic shock\n* Currently participating in an investigational drug or another device study\n* Lack of capability to give informed consent\n* Patient refuses TAVI'}, 'identificationModule': {'nctId': 'NCT07399392', 'acronym': 'RADIAL-TAVI', 'briefTitle': 'Radial Versus Femoral Secondary Access in Patients Undergoing TAVI', 'organization': {'class': 'OTHER', 'fullName': 'University Heart Center Freiburg - Bad Krozingen'}, 'officialTitle': 'Radial Versus Femoral Secondary Access in Patients Undergoing TAVI', 'orgStudyIdInfo': {'id': '25-1058-S1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 Radial', 'description': 'Group 1: patients with radial secondary arterial access', 'interventionNames': ['Procedure: Radial TAVI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 femoral', 'description': 'Group 2: patients with femoral secondary arterial access', 'interventionNames': ['Procedure: femoral TAVI']}], 'interventions': [{'name': 'Radial TAVI', 'type': 'PROCEDURE', 'description': 'patients will recieve the TAVI intervention via radial access', 'armGroupLabels': ['Group 1 Radial']}, {'name': 'femoral TAVI', 'type': 'PROCEDURE', 'description': 'patients will recieve the TAVI intervention via femoral access', 'armGroupLabels': ['Group 2 femoral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79106', 'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Constantin von zur Muehlen, MD', 'role': 'CONTACT', 'email': 'constantin.vonzurmuehlen@uniklinik-freiburg.de', 'phone': '+49 761 270 34415'}], 'facility': 'University Heart Center - Deparment for Cardiology and Angiology', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'centralContacts': [{'name': 'Constantin von zur Muehlen, MD', 'role': 'CONTACT', 'email': 'constantin.vonzurmuehlen@uniklinik-freiburg.de', 'phone': '+49 761 270 34415'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Shared IPD from clinical trials used for further scientific research will be stored in a secure processing environment and, depending on the request for secondary use, will be made accessible either as pseudonymised or anonymised datasets.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Heart Center Freiburg - Bad Krozingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}