Abdominal Aortic Aneurysm Clinical Trial
— CEVARIIOfficial title:
Complex Endovascular Aortic Repair in Inflammatory and Infective Perivisceral Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms (CEVARII)
Verified date | April 2024 |
Source | CEVARII |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 220 |
Est. completion date | March 2026 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Patients 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. Exclusion Criteria: - Suboptimal documentation of clinical, laboratory, and imaging findings - Presence of prosthetic material (endograft or open graft material) - Prior open or endovascular aortic repair - Findings suspicious of secondary aorto-enteric or -bronchial fistulas. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Healthcare | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
CEVARII | University of Colorado, Colorado Springs, University of Colorado, Denver, University of Copenhagen, University of Iowa, University of Trieste |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Graft Patency | Defined as uninterrupted blood flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months | up to 36 months | |
Primary | Bowel Ischemia | Bowel Ischemia requiring surgical resection/not resolving with medical therapy. Outcome measures include the number of Participants with bowel ischemia after surgery. | 30 days | |
Primary | Presence of aortic aneurysm endoleak after surgery | 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. | up to 30 days | |
Primary | Aneurysm-related mortality (ARM) | Outcome measures include the number of participants who died 30 days after the procedure. | up to 30 days | |
Primary | Conversion to Open Surgical Repair (OSR) | Outcome measures include the number of participants whose cases converted from endovascular aortic aneurysm repair to open surgical repair. | up to 30 days | |
Primary | Aortic rupture | Outcome measures include the number of participants who had aortic rupture. | up to 30 days. | |
Primary | Post-operative infection-related complication (IRC) | 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. | up to 24 months | |
Primary | The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies. | 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 | up to 36 months | |
Secondary | Assessment of Adverse Events (AEs) described in the protocol. | Follow-up timeframes - 1, 6, 12, 24, and 36 months | up to 36 months | |
Secondary | All Cause Mortality | Any death occurring during the study period, regardless of cause. Timeframes: 1 yeas and 2 years | 24 months | |
Secondary | Continued Aortic sac growth. | Outcome measures include the number of participants who had continued sac growth (> 0.5 mm/6 month) despite appropriate reinterventions. | up to 24 months |
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