Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-25 @ 7:54 AM
Study NCT ID:
NCT05777460
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2023-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mid- and Long-term Outcomes of Custom-made Aortic Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D017545', 'term': 'Aortic Aneurysm, Thoracic'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000094682', 'term': 'Endovascular Aneurysm Repair'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019917', 'term': 'Blood Vessel Prosthesis Implantation'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-15', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-03-09', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Mortality', 'timeFrame': '3 years', 'description': 'Any death occurring during follow-up'}, {'measure': 'Aortic-related mortality', 'timeFrame': '3 years', 'description': 'Any death occurring during follow-up and related to the procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortic Diseases', 'Thoracic Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate mid- and long-term outcomes after Thoracic endovascular aortic repair (TEVAR) with custom-made devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients that underwent Thoracic Endovascular Aortic Repair (TEVAR) in the period 2015-2023 with the Custom Relay® Multi-Feature™ Terumo Aortic will be included in the analysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thoracic Aortic Disease\n\nExclusion Criteria:\n\n* Urgent/Emergent treatment'}, 'identificationModule': {'nctId': 'NCT05777460', 'briefTitle': 'Mid- and Long-term Outcomes of Custom-made Aortic Devices', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Results From a Multicenter Registry on the Outcomes of the Terumo Custom-made Aortic Endograft', 'orgStudyIdInfo': {'id': '2992'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Thoracic endovascular aortic repair (TEVAR)', 'type': 'DEVICE', 'description': 'The TEVAR procedure involves the placement of a covered stent (a metal mesh tube with a layer of fabric) into the weakened area of the artery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00167', 'city': 'Roma', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Tinelli', 'role': 'CONTACT', 'email': 'giovanni.tinelli@policlinicogemelli.it', 'phone': '0039 0630157205'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Giovanni Tinelli', 'role': 'CONTACT', 'email': 'giovanni.tinelli@policlinicogemelli.it', 'phone': '\u202d+39 347 4864020\u202c'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'TINELLI GIOVANNI', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}