Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms

Launched by CEVARII · Apr 20, 2024

Keywords

ClinConnect Summary

The CEVARII study is an international registry that collects information on how doctors manage two rare and serious aortic problems: inflammatory abdominal aortic aneurysms (IAA) and infective native abdominal or thoracoabdominal aneurysms (INAA). It looks at real-world use of complex endovascular repair, a minimally invasive surgery that uses special grafts, to see how patients do after this treatment. This is an observational study, meaning it just observes and collects data rather than testing a new drug or device. The goal is to understand outcomes and help doctors reach better, evidence-based ways to treat these conditions.

If you are eligible, you would be an adult 18 years or older with a confirmed IAA or INAA who has already been treated with complex endovascular repair at a participating center. People with incomplete medical records, prior grafts, or suspected aorto-enteric fistulas are not eligible. Participation involves collecting information from medical records and following patients for up to about 3 years, with check-ins at 1, 6, 12, 24, and 36 months. The main things the study tracks are whether the graft stays open without more procedures, risks of bowel problems or leaks around the graft, death within 30 days of the procedure, conversion to open surgery, rupture, and infection-related complications, plus how long antibiotics or immune-suppressing medicines are used. The study plans to enroll about 220 people and is currently enrolling by invitation, with an estimated completion around 2026.

Gender

ALL

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.