EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)- A Randomized Controlled Multicentre Study in Germany

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie
RECRUITING
Munich
Contact Information
Primary
Christoph Knappich, PD Dr. med.
christoph.knappich@mri.tum.de
0049-894140
Backup
Marie Kristin Fritsche, Dr. rer. nat.
mariekristin.fritsche@mri.tum.de
0046-894140
Time Frame
Start Date: 2023-01-15
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 100
Treatments
Experimental: EVAR with SE
Patients in the EVAR-SE arm will receive EVAR with additional coil embolization of the aneurysm sac.
No_intervention: standard EVAR
Patients in the standard EVAR arm will receive EVAR without additional coil embolization of the aneurysm sac.
Sponsors
Leads: Christoph Knappich
Collaborators: University Hospital Carl Gustav Carus, Technical University of Munich, University Hospital Augsburg, St. Josefs-Hospital Wiesbaden GmbH

This content was sourced from clinicaltrials.gov