Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms

• Conditions: Aneurysm, Infected; Aneurysm, Mycotic; Inflammatory Abdominal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm; Abdominal Aortic Aneurysm
• Interventions: Procedure: Complex endovascular aortic repair (cEVAR)

• Registration Number: NCT06380595
• Lead Sponsor: CEVARII

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.

Study Timeline

• Study Start: 2024-02-21
• Study First Submitted: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-20
• Last Update Submitted: 2024-04-20
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inflammatory aortic aneurysms (IAA)	Complex endovascular aortic repair (cEVAR)	Inflammatory aortic aneurysms (IAA) are rare but highly morbid conditions that pose unique diagnostic and therapeutic challenges to the vascular surgeon. Patients with confirmed IAA who were treated with complex endovascular techniques at participating centers will be included in the registry.
Infective Native Abdominal Aortic Aneurysms (INAA)	Complex endovascular aortic repair (cEVAR)	Infective native aortic aneurysms (INAA) are rare but highly morbid conditions that pose unique diagnostic and therapeutic challenges to the vascular surgeon. Patients with confirmed NAA who were treated with complex endovascular techniques at participating centers will be included in the registry.

Primary Outcome Measures

Name	Time	Method
Conversion to Open Surgical Repair (OSR)	up to 30 days	Outcome measures include the number of participants whose cases converted from endovascular aortic aneurysm repair to open surgical repair.
Primary Graft Patency	up to 36 months	Defined as uninterrupted blood flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months
Aneurysm-related mortality (ARM)	up to 30 days	Outcome measures include the number of participants who died 30 days after the procedure.
Bowel Ischemia	30 days	Bowel Ischemia requiring surgical resection/not resolving with medical therapy. Outcome measures include the number of Participants with bowel ischemia after surgery.
Presence of aortic aneurysm endoleak after surgery	up to 30 days	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.
Aortic rupture	up to 30 days.	Outcome measures include the number of participants who had aortic rupture.
Post-operative infection-related complication (IRC)	up to 24 months	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.
The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies.	up to 36 months	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

Secondary Outcome Measures

Name	Time	Method
Continued Aortic sac growth.	up to 24 months	Outcome measures include the number of participants who had continued sac growth (\> 0.5 mm/6 month) despite appropriate reinterventions.
All Cause Mortality	24 months	Any death occurring during the study period, regardless of cause. Timeframes: 1 yeas and 2 years
Assessment of Adverse Events (AEs) described in the protocol.	up to 36 months	Follow-up timeframes - 1, 6, 12, 24, and 36 months

Trial Locations

Locations (1)

University of Colorado Healthcare; 🇺🇸 Aurora, Colorado, United States