Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-20 @ 2:09 AM
Study NCT ID:
NCT07118995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ANATOMICAL FEASIBILITY OF BRAILE STANDARD BRANCHED ENDOGRAFT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094624', 'term': 'Aortic Aneurysm, Thoracoabdominal'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}], 'ancestors': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical feasibility and applicability of off-the-shelf multi-branched endografts from two device models', 'timeFrame': 'completion of the anatomical assessment', 'description': 'Number of patients with anatomical characteristics suitable for the theoretical use of the new Braile off-the-shelf multi-branched endograft.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracoabdominal aortic aneurysm', 'Off-the-shelf endograft', 'Anatomical feasibility'], 'conditions': ['Thoracoabdominal Aortic Aneurysm', 'Endovascular Repair of Aortic Aneurysm', 'Vascular Diseases', 'Aortic Diseases', 'Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'The objective of this retrospective observational study is to evaluate the theoretical anatomical suitability of the new Braile off-the-shelf multi-branched endograft in patients with thoracoabdominal aneurysm. One hundred preoperative contrast-enhanced computed tomography angiographies (CTAs) from patients previously treated with a custom-made endograft will be analyzed. The hypothesis is that a significant proportion of these patients will have anatomical features compatible with the use of the new endograft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with thoracoabdominal aortic aneurysm', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Preoperative CTA images from patients previously treated with Braile's custom-made multi-branched endograft for thoracoabdominal aneurysm.\n* Contrast-enhanced CTAs covering the thorax, abdomen, and pelvis, with thin slices of 1 to 2 mm, available in Braile's imaging database.\n\nExclusion Criteria:\n\n• Exams with incomplete or inadequate images, defined as CTAs with slice thickness greater than 2 mm"}, 'identificationModule': {'nctId': 'NCT07118995', 'acronym': 'BMETA', 'briefTitle': 'ANATOMICAL FEASIBILITY OF BRAILE STANDARD BRANCHED ENDOGRAFT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Braile Biomedica Ind. Com. e Repr. Ltda.'}, 'officialTitle': 'Anatomical Feasibility of the Braile Off-the-Shelf Multi-Branched Endograft for the Treatment of Thoracoabdominal Aneurysm', 'orgStudyIdInfo': {'id': 'BMETA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated for TAA', 'description': 'Patients with thoracoabdominal aortic aneurysms treated with a custom-designed multi-branched endograft.', 'interventionNames': ['Other: Analysis of preoperative CTA']}], 'interventions': [{'name': 'Analysis of preoperative CTA', 'type': 'OTHER', 'description': "A review of preoperative contrast-enhanced CTA from patients with thoracoabdominal aneurysms, included in Braile's database, who were indicated for endovascular treatment with Braile's custom-made multi-branched endograft between 2022 and 2024", 'armGroupLabels': ['Patients treated for TAA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Moinho de Ventos', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Alexandre A Pereira', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Moinho de Ventos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Braile Biomedica Ind. Com. e Repr. Ltda.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}