Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT05892367
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2018-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D006406', 'term': 'Hematoma'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Control group: compression bandage Study group: compression bandage and positioning splint'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-27', 'studyFirstSubmitDate': '2018-02-04', 'studyFirstSubmitQcDate': '2023-05-27', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of local complications at the puncture site', 'timeFrame': '6 weeks', 'description': 'Local complications as hematoma, bleeding, pseudoaneurysm, arterial dissection, arterial stenosis, arterial occlusion, AV fistula detected by ultrasound 24 hours after intervention and at time of follow-up six weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'Post-interventional pain at puncture site', 'timeFrame': '24 hours', 'description': 'Evaluation of local pain according to V.A.S. score by asking patients after intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transbrachial access, intervention, bleeding, hematoma'], 'conditions': ['Complication of Treatment']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is an evaluation, whether an immobilization of the upper extremity by means of a positioning splint can help to reduce the incidence of local complications after transbrachial puncture for peripheral arterial interventions, or not.', 'detailedDescription': 'Increasing numbers of peripheral arterial interventions are performed via transbrachial access leading to a higher number of local complications at the puncture site. Patients are demonstrating complications, such as hematoma, false aneurysm, secondary hemorrhage and arterial stenosis or occlusion.\n\nDue to not standardized post-interventional procedure regarding to immobilization a higher risk for local puncture site complication can occur. Usually, a compression bandage its applied to the brachial puncture site. Within this randomized study, patients randomized to the study group will receive an additional splint for 24 hours to ensure an immobilization of the affected arm.\n\nFollowing the removal of the compression dressing, and the splint in the study group, a duplex ultrasound its performed in order to detect local alterations and pathologies of the brachial artery.\n\nThis examination is repeated for each patient in the course of an outpatient control six weeks post-interventionally. Pathologies are documented and treated if necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male patients suffering from peripheral arterial occlusive disease with indicated interventions via an transbrachial access (puncture of the left or right brachial artery)\n* age \\> 18 years\n* approval to participate\n\nExclusion Criteria:\n\n* unability or refusal to participate\n* dialysis patients/AV-fistula interventions\n* usage of closure devices'}, 'identificationModule': {'nctId': 'NCT05892367', 'acronym': 'TBA', 'briefTitle': 'Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease', 'organization': {'class': 'OTHER', 'fullName': 'Wilhelminenspital Vienna'}, 'officialTitle': 'Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease: Evaluation of Local Complications With or Without Post-interventional Immobilization of the Upper Extremity', 'orgStudyIdInfo': {'id': 'TBA 1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control group', 'description': 'Application of a compression bandage following transbrachial puncture for 24 hours', 'interventionNames': ['Other: Transbrachial Access for Interventions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study group', 'description': 'Application of a compression bandage and a positioning splint following transbrachial puncture for 24 hours', 'interventionNames': ['Other: Transbrachial Access for Interventions']}], 'interventions': [{'name': 'Transbrachial Access for Interventions', 'type': 'OTHER', 'description': 'Adding a positioning splint in addition to compression bandage after intervention in order to guarantee immobilization of puncture site', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1160', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Department of Vascular and Endovascular Surgery', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Afshin Assadian, Prim. PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vascular and Endovascular Surgery, Klinik Ottakring'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wilhelminenspital Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Edda Skrinjar, M.D.', 'investigatorAffiliation': 'Wilhelminenspital Vienna'}}}}