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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniv.-Prof. Dr. Dr. med. Daniela Branzan

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Ruptured AAA

Fenestrated or branched EVAR

Concomitant iliac artery aneurysm

Non-ability to adhere to the FU protocol

Trial design

Treatments tested in this trial

  • Coil embolization of aneurysm sac

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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