Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-30 @ 8:13 PM
Study NCT ID:
NCT05530304
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2022-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094626', 'term': 'Aneurysm, Aortic Arch'}, {'id': 'D000094629', 'term': 'Dissection, Thoracic Aorta'}], 'ancestors': [{'id': 'D017545', 'term': 'Aortic Aneurysm, Thoracic'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D000784', 'term': 'Aortic Dissection'}, {'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days after intervention'}, {'measure': 'feasibility in terms of cannulation and stentgrafting of the three branches', 'timeFrame': 'During intervention'}, {'measure': 'Stroke', 'timeFrame': '30 days after intervention'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'during the follow up period of 3 year', 'description': 'Access issue, paraplegia, kidney failure'}, {'measure': 'Endoleaks Type I and III', 'timeFrame': 'during intervention and the follow up period of 3 year'}, {'measure': 'Longterm mortality', 'timeFrame': 'during the follow up period of 3 year'}, {'measure': 'Patency rate of branches', 'timeFrame': 'during the follow up period of 3 year', 'description': 'primary and secondary'}, {'measure': 'Stroke', 'timeFrame': 'during the follow up period of 3 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic arch pathologies', 'Aortic arch aneruysm', 'Aortic arch dissection', 'triple branch', 'stentgraft', 'Double branch', 'Inner branch'], 'conditions': ['Aortic Arch', 'Aortic Arch Aneurysm', 'Dissection of Aortic Arch', 'Triple Branch']}, 'descriptionModule': {'briefSummary': 'Outcome of a triple inner branched aortic arch stentgraft. A prospective, mulitcenter registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will be recruited from patients presenting to participating hospitals with aortic pathology and meeting inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Presence of Aortic arch pathology\n* Treatment planned with triple inner branch from Terumo Aortic\n* Availability of the patients during the follow up period\n* Informing patients about the study and providing written informed consent\n\nExclusion Criteria:\n\n* Women of childbearing age\n* Patients under 18 years'}, 'identificationModule': {'nctId': 'NCT05530304', 'acronym': 'triple_branch', 'briefTitle': 'Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.', 'orgStudyIdInfo': {'id': 'University_Hospital_Muenster'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Triple inner branched arch stentgraft', 'type': 'DEVICE', 'description': 'New findings regarding treatment planning and management of patients with aortic arch pathologies.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexander Oberhuber, MD Phd', 'role': 'CONTACT', 'email': 'alexander.oberhuber@ukmuenster.de', 'phone': '+49 251 8345781'}, {'name': 'Alexander Oberhuber, MD Phd', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Muenster University Hospital', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'centralContacts': [{'name': 'Alexander Oberhuber, MD, PhD', 'role': 'CONTACT', 'email': 'alexander.oberhuber@ukmuenster.de', 'phone': '+49 251 8345781'}, {'name': 'vascular trial unit', 'role': 'CONTACT', 'email': 'vital@ukmuenster.de', 'phone': '+49 251 8351717'}], 'overallOfficials': [{'name': 'Alexander Oberhuber, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Vascular and Endovascular Surgery University Hospital Münster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.-Prof. Dr. med.', 'investigatorFullName': 'Univ.-Prof. Dr. med. Alexander Oberhuber', 'investigatorAffiliation': 'University Hospital Muenster'}}}}