EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study) (EVAR-SE)
Abdominal Aortic Aneurysm, Endoleak
About this trial
This is an interventional prevention trial for Abdominal Aortic Aneurysm focused on measuring Abdominal Aortic Aneurysm, Endoleak, Endovascular aortic aneurysm repair, Coiling, Endoleak Type II
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
Sites / Locations
- Klinikum rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre ChirurgieRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
EVAR with SE
standard EVAR
Patients in the EVAR-SE arm will receive EVAR with additional coil embolization of the aneurysm sac.
Patients in the standard EVAR arm will receive EVAR without additional coil embolization of the aneurysm sac.