Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-29 @ 6:30 PM
Study NCT ID:
NCT05401669
Status:
RECRUITING
Last Update Posted:
2024-09-04
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transradial Versus Transfemoral Access for Cerebral Angiography
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 748}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-06-01', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of successful diagnostic cerebral angiography', 'timeFrame': '24 hours', 'description': 'the successful superselection of the aortic arch vessel without changing the arterial approach, with angiography results meeting diagnostic requirements'}], 'secondaryOutcomes': [{'measure': 'the rate of successful accurate diagnosis', 'timeFrame': '24 hours'}, {'measure': 'the duration of angiography', 'timeFrame': 'During procedure', 'description': 'time taken to do the full procedure'}, {'measure': 'the duration of fluoroscopy', 'timeFrame': 'During procedure', 'description': 'Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic cerebral angiography'}, {'measure': 'the bedridden time', 'timeFrame': '24 hours'}, {'measure': 'the Visual Analogue Scale (VAS) score', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral Angiography', 'Transfemoral Arterial access', 'Transradial Arterial access'], 'conditions': ['Cerebral Angiography']}, 'descriptionModule': {'briefSummary': 'This study is multi-center, prospective, randomized (1:1) controlled trial designed to assess and compare the feasibility, safety and success of Transradial access (TRA) versus Transfemoral access (TFA) for diagnostic cerebral angiography.', 'detailedDescription': 'TFA is traditional approach for diagnostic cerebral angiography, which has several limitations and complications including pain and discomfort, retroperitoneal hemorrhage, pulmonary embolism and increased admissions. Transradial coronary angiography has demonstrated preponderance to circumvent this limitations and complications. However, this has not been studied in cerebral angiography. So, the purpose of this study is to assess and compare the feasibility, safety and success of TRA versus TFA for diagnostic cerebral angiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 80 years old;\n2. Scheduled to undergo diagnostic cerebral angiography;\n3. Suitable for cerebral angiography via TRA and TFA access, with a radial artery diameter ≥2mm confirmed by ultrasonography;\n4. Modified Rankin Scale (mRS) score ≤2;\n5. Provided written informed consent.\n\nExclusion Criteria:\n\n1. Severe stenosis of the radial, brachial, subclavian, brachiocephalic, iliac or common femoral arteries, or any significant vascular disease (such as aortic aneurysm, etc.) that may obstruct guidewire passage;\n2. Arteriovenous fistula for hemodialysis present in the right upper limb;\n3. Planned interventional surgery within 24 hours of the initial study angiography;\n4. Requirement for cerebral angiography in an emergency department;\n5. Use of general anesthesia;\n6. Any contraindication to cerebral angiography, such as allergy or intolerance to the contrast media, uncorrected severe coagulation disorders, arterial dissection in the target vessel, puncture site infection, or renal insufficiency (Creatinine \\[Gr\\] \\> 3 times of the upper limit of normal \\[ULN\\]), etc.;\n7. Women who are pregnant or planning to become pregnant within 1 year;\n8. Participation in another clinical trial;\n9. Any other condition deemed unsuitable for participation by the investigator.'}, 'identificationModule': {'nctId': 'NCT05401669', 'briefTitle': 'Transradial Versus Transfemoral Access for Cerebral Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'Transradial Versus Transfemoral Access for Cerebral Angiography', 'orgStudyIdInfo': {'id': '2021Y9308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trans-radial artery access', 'interventionNames': ['Procedure: Trans-radial access']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trans-femoral Artery access', 'interventionNames': ['Procedure: Trans-femoral access']}], 'interventions': [{'name': 'Trans-radial access', 'type': 'PROCEDURE', 'description': 'Cerebral angiography performed by trans-radial access', 'armGroupLabels': ['Trans-radial artery access']}, {'name': 'Trans-femoral access', 'type': 'PROCEDURE', 'description': 'Cerebral angiography performed by trans-femoral access', 'armGroupLabels': ['Trans-femoral Artery access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shangai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Heng Yang, PhD,MD', 'role': 'CONTACT', 'email': 'yangheng901109@163.com', 'phone': '13162909815'}], 'facility': 'Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Heng Yang, PhD, MD', 'role': 'CONTACT', 'email': 'yangheng9011090@163.com', 'phone': '13162909815'}], 'overallOfficials': [{'name': 'Yuxiang Gu, PhD,MD', 'role': 'STUDY_CHAIR', 'affiliation': 'department of Neurosurgery, Huashan Hospital,Fudan University'}, {'name': 'Wei Ni, PhD,MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'department of Neurosurgery, Huashan Hospital,Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice-president of Huashan Hospital west campus', 'investigatorFullName': 'Yuxiang Gu', 'investigatorAffiliation': 'Huashan Hospital'}}}}