Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture.
Secondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.
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
Ruptured AAA
Fenestrated or branched EVAR
Concomitant iliac artery aneurysm
Non-ability to adhere to the FU protocol
Parallel
Coil embolization of aneurysm sac
Procedure/SurgeryPatients are treated with standard EVAR with additional coiling of the aneurysm sac. The distinct type of coils used is not predefined.
Type II Endoleak at 12 months after procedure
Evaluation of the T2EL proportion of the intervention group as compared to the control group at 12 months after EVAR treatment as measured by CEUS and/or CT-A
Type II Endoleak during follow up
T2EL 2-4 days after EVAR treatment detected by CEUS and/or CT-A
Type II Endoleak during follow up
T2EL 30 days after EVAR treatment detected by CEUS and/or CT-A
Type II Endoleak during follow up
T2EL 6 months after EVAR treatment detected by CEUS and/or CT-A
Re-intervention
Rates of any re-intervention (for endoleaks, occlusions, graft infection, graft migration)
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Univ.-Prof. Dr. Dr. med. Daniela Branzan
Lead sponsor
Technical University of Munich
Sponsor institution
Technical University of Munich
Collaborator
St. Josefs-Hospital Wiesbaden GmbH
Collaborator
University Hospital Augsburg
Collaborator
University Hospital Carl Gustav Carus
Collaborator
