EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)

Launched by UNIV.-PROF. DR. MED. HANS-HENNING ECKSTEIN · Dec 16, 2022

Keywords

ClinConnect Summary

The EVAR-SE Study is a clinical trial that is investigating a new way to prevent a complication called type II endoleak (T2EL) after a procedure for treating abdominal aortic aneurysms (AAA). An AAA is a bulge in the aorta, the large blood vessel that carries blood from the heart to the rest of the body. During a procedure called endovascular aortic aneurysm repair (EVAR), a stent-graft is placed to seal off the aneurysm. However, in some cases, blood can flow back into the aneurysm, which can lead to serious problems like the aneurysm growing or even rupturing. This study aims to see if placing metal coils in the aneurysm sac during the EVAR procedure can help lower the risk of T2EL.

To participate in this trial, individuals should be at least 18 years old and have an AAA that is 50 mm or larger. They must also meet certain criteria based on imaging tests that show they might be at high risk for developing T2EL. Participants can expect to receive the standard EVAR treatment along with the additional procedure of placing coils to help prevent the complication. This study is currently recruiting participants, and it is important that volunteers are able to follow up as required and provide consent to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Infrarenal AAA ≥50 mm maximum diameter
• • Indication for EVAR within IFU of company
• • Presence of one or both high risk criteria on CT-A: ≥5 patent efferent vessels (inferior mesenteric and/or lumbar artery, and/or median sacral artery) or \<40% thrombus at largest AAA diameter
• Exclusion Criteria:
• • Ruptured AAA
• • Fenestrated or branched EVAR
• • Concomitant iliac artery aneurysm
• • Non-ability to adhere to the FU protocol
• • Lack of consent
• • Pregnancy