Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms (CEVARII)

CEVARII

Status: Invitation-only

Conditions: Aneurysm, Mycotic; Inflammatory Abdominal Aortic Aneurysm; Abdominal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm; Aneurysm, Infected

Treatments: Procedure: Complex endovascular aortic repair (cEVAR)

Study type: Observational

Funder types: Other

Identifiers

NCT06380595

23 -1533

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

220 participants in 2 patient groups

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. Patients with confirmed NAA who were treated with complex endovascular techniques at participating centers will be included in the registry.

Treatment:

Procedure: Complex endovascular aortic repair (cEVAR)

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. Patients with confirmed IAA who were treated with complex endovascular techniques at participating centers will be included in the registry.

Treatment:

Procedure: Complex endovascular aortic repair (cEVAR)