Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-02-20 @ 12:30 PM
Study NCT ID:
NCT06380595
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-24
First Post:
2024-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000785', 'term': 'Aneurysm, Infected'}, {'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D000094624', 'term': 'Aortic Aneurysm, Thoracoabdominal'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-20', 'studyFirstSubmitDate': '2024-03-01', 'studyFirstSubmitQcDate': '2024-04-20', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Graft Patency', 'timeFrame': 'up to 36 months', 'description': 'Defined as uninterrupted blood flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months'}, {'measure': 'Bowel Ischemia', 'timeFrame': '30 days', 'description': 'Bowel Ischemia requiring surgical resection/not resolving with medical therapy. Outcome measures include the number of Participants with bowel ischemia after surgery.'}, {'measure': 'Presence of aortic aneurysm endoleak after surgery', 'timeFrame': 'up to 30 days', 'description': 'The technical repair success is defined as the exclusion of the aneurysm without Type I/III endoleak, and with preservation of at least the Superior Mesenteric Artery or the Celiac Artery. Outcome measures include the number of participants with type I endoleak, and the number of participants with type III endoleak.'}, {'measure': 'Aneurysm-related mortality (ARM)', 'timeFrame': 'up to 30 days', 'description': 'Outcome measures include the number of participants who died 30 days after the procedure.'}, {'measure': 'Conversion to Open Surgical Repair (OSR)', 'timeFrame': 'up to 30 days', 'description': 'Outcome measures include the number of participants whose cases converted from endovascular aortic aneurysm repair to open surgical repair.'}, {'measure': 'Aortic rupture', 'timeFrame': 'up to 30 days.', 'description': 'Outcome measures include the number of participants who had aortic rupture.'}, {'measure': 'Post-operative infection-related complication (IRC)', 'timeFrame': 'up to 24 months', 'description': 'Outcome measures include the number of participants who had a new post-operative infection-related complication (IRC) in treated aortic segments or endograft, new IRC in contiguous aortic segments, or persistent sepsis.'}, {'measure': 'The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies.', 'timeFrame': 'up to 36 months', 'description': 'Duration of antibiotics (in days) prescribed for Infective aortic aneurysm patients before and after the surgery. Duration of immunosuppressive drugs (in days) for inflammatory aortic aneurysm patients before and after the surgery'}], 'secondaryOutcomes': [{'measure': 'Assessment of Adverse Events (AEs) described in the protocol.', 'timeFrame': 'up to 36 months', 'description': 'Follow-up timeframes - 1, 6, 12, 24, and 36 months'}, {'measure': 'All Cause Mortality', 'timeFrame': '24 months', 'description': 'Any death occurring during the study period, regardless of cause. Timeframes: 1 yeas and 2 years'}, {'measure': 'Continued Aortic sac growth.', 'timeFrame': 'up to 24 months', 'description': 'Outcome measures include the number of participants who had continued sac growth (\\> 0.5 mm/6 month) despite appropriate reinterventions.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infected', 'Mycotic', 'Inflammatory', 'Aortic Aneurysm', 'INAA', 'IAA', 'Infective Native', 'Complex endovascular aortic repair'], 'conditions': ['Inflammatory Abdominal Aortic Aneurysm', 'Aneurysm, Infected', 'Aneurysm, Mycotic', 'Abdominal Aortic Aneurysm', 'Thoracoabdominal Aortic Aneurysm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://cevarii.com/', 'label': 'CEVARII research project information and updates'}, {'url': 'https://redcap.link/CEVARII', 'label': 'CEVARII research project sign up link for interested sites.'}]}, 'descriptionModule': {'briefSummary': 'Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. Ethical approval for the study was obtained from the Colorado Multiple Institutional Review Board (COMIRB) under protocol number 23-1533.', 'detailedDescription': 'Infective Native and Inflammatory Aortic Aneurysms (INAA \\& IAA) are rare, morbid conditions with unique challenges. INAA \\& IAA share clinical and imaging similarities but differ significantly in pathophysiology, management, and prognosis. Open surgical repair of INAA \\& IAA is technically challenging and associated with higher complications.\n\nComplex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international consortium effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. CEVARII study is IRB approved with the number 23-1533.\n\nKnowledge gained will help generate consensus on how to best manage patients with inflammatory and infective aortic aneurysms involving the visceral and thoracoabdominal aorta.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will consist of two separate cohorts: 1) inflammatory aortic aneurysms (IAA) and 2) infective native aortic aneurysms (INAA). Patients with confirmed IAA or INAA who were treated with complex endovascular techniques at participating centers will be included in the registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients aged ≥ 18 years old with a diagnosis of inflammatory abdominal aortic aneurysm (IAA) or infective native aortic aneurysms (INAA), who have undergone complex endovascular aortic repair (cEVAR) are eligible for inclusion in this study.\n\nExclusion Criteria:\n\n* Suboptimal documentation of clinical, laboratory, and imaging findings\n* Presence of prosthetic material (endograft or open graft material)\n* Prior open or endovascular aortic repair\n* Findings suspicious of secondary aorto-enteric or -bronchial fistulas.'}, 'identificationModule': {'nctId': 'NCT06380595', 'acronym': 'CEVARII', 'briefTitle': 'Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms', 'organization': {'class': 'OTHER', 'fullName': 'CEVARII'}, 'officialTitle': 'Complex Endovascular Aortic Repair in Inflammatory and Infective Perivisceral Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms (CEVARII)', 'orgStudyIdInfo': {'id': '23 -1533'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infective Native Abdominal Aortic Aneurysms (INAA)', 'description': 'Infective native aortic aneurysms (INAA) are rare but highly morbid conditions that pose unique diagnostic and therapeutic challenges to the vascular surgeon.\n\nPatients with confirmed NAA who were treated with complex endovascular techniques at participating centers will be included in the registry.', 'interventionNames': ['Procedure: Complex endovascular aortic repair (cEVAR)']}, {'label': 'Inflammatory aortic aneurysms (IAA)', 'description': 'Inflammatory aortic aneurysms (IAA) are rare but highly morbid conditions that pose unique diagnostic and therapeutic challenges to the vascular surgeon.\n\nPatients with confirmed IAA who were treated with complex endovascular techniques at participating centers will be included in the registry.', 'interventionNames': ['Procedure: Complex endovascular aortic repair (cEVAR)']}], 'interventions': [{'name': 'Complex endovascular aortic repair (cEVAR)', 'type': 'PROCEDURE', 'description': 'Complex endovascular aortic repair (cEVAR) collectively refers to the use of fenestrated/branched EVAR (f/bEVAR) or other EVAR variations allowing alternative visceral incorporation approaches, such as laser or radiofrequency (RF) fenestration or parallel endografts (snorkel, periscope, chimney or sandwich EVAR) to enable repair of perivisceral AAA (pvAAA), thoracoabdominal aortic aneurysms (TAAA), and aortic arch aneurysms.', 'armGroupLabels': ['Infective Native Abdominal Aortic Aneurysms (INAA)', 'Inflammatory aortic aneurysms (IAA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Healthcare', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'MEL J Sharafuddin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Hospital Central, University of Colorado Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CEVARII', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Iowa', 'class': 'OTHER'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'University of Trieste', 'class': 'OTHER'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'University of Colorado, Colorado Springs', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor of Surgery and Radiology', 'investigatorFullName': 'Mel J. Sharafuddin, MD, FACS, FSIR', 'investigatorAffiliation': 'University of Colorado, Colorado Springs'}}}}