NCT06380595

Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms

Complex Endovascular Aortic Repair in Inflammatory and Infective Perivisceral Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms (CEVARII)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: CEVARII · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Abdominal Aortic Aneurysm
• Aneurysm, Infected
• Aneurysm, Mycotic
• Abdominal Aortic Aneurysm
• Thoracoabdominal Aortic Aneurysm

Interventions

Type	Name	Description
PROCEDURE	Complex endovascular aortic repair (cEVAR)	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.

Timeline

• Start date: 2024-02-21
• Primary completion: 2025-03-01
• Completion: 2026-03-01
• First posted: 2024-04-24
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States