Clinical trial NCT06380595: Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms
Official title: Complex Endovascular Aortic Repair in Inflammatory and Infective Perivisceral Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms (CEVARII)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Inflammatory Abdominal Aortic Aneurysm
Aneurysm, Infected
Aneurysm, Mycotic
Abdominal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm
Keywords: Infected
Mycotic
Inflammatory
Aortic Aneurysm
INAA
IAA
Infective Native
Complex endovascular aortic repair
Lead sponsor: CEVARII
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: University of Colorado, Denver
name: University of Trieste
name: University of Copenhagen
name: University of Colorado, Colorado Springs
First posted: 2024-04-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Complex 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.

Knowledge gained will help generate consensus on how to best manage patients with inflammatory and infective aortic aneurysms involving the visceral and thoracoabdominal aorta.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Graft Patency
timeFrame: up to 36 months
measure: Bowel Ischemia
timeFrame: 30 days
measure: Presence of aortic aneurysm endoleak after surgery
timeFrame: up to 30 days
measure: Aneurysm-related mortality (ARM)
timeFrame: up to 30 days
measure: Conversion to Open Surgical Repair (OSR)
timeFrame: up to 30 days
measure: Aortic rupture
timeFrame: up to 30 days.
measure: Post-operative infection-related complication (IRC)
timeFrame: up to 24 months
measure: The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies.
timeFrame: up to 36 months
Secondary outcomes:
measure: Assessment of Adverse Events (AEs) described in the protocol.
timeFrame: up to 36 months
measure: All Cause Mortality
timeFrame: 24 months
measure: Continued Aortic sac growth.
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Healthcare
state: Colorado
Study officials:
affiliation: Memorial Hospital Central, University of Colorado Healthcare
name: MEL J Sharafuddin, MD
role: PRINCIPAL_INVESTIGATOR
References: