Endovascular aortic repair with sac embolization for the prevention of type II endoleaks (the EVAR-SE study): study protocol for a randomized controlled multicentre study in Germany

Autor: Christoph Knappich, Felix Kirchhoff, Marie-Kristin Fritsche, Silvia Egert-Schwender, Heiko Wendorff, Michael Kallmayer, Bernhard Haller, Alexander Hyhlik-Duerr, Christian Reeps, Hans-Henning Eckstein, Matthias Trenner
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Trials, Vol 25, Iss 1, Pp 1-12 (2024)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-023-07888-8
Popis: Abstract Background Beyond a certain threshold diameter, abdominal aortic aneurysms (AAA) are to be treated by open surgical or endovascular aortic aneurysm repair (EVAR). In a quarter of patients who undergo EVAR, inversion of blood flow in the inferior mesenteric artery or lumbar arteries may lead to type II endoleak (T2EL), which is associated with complications (e.g. AAA growth, secondary type I endoleak, rupture). As secondary interventions to treat T2EL often fail and may be highly invasive, prevention of T2EL is desirable. The present study aims to assess the efficacy of sac embolization (SE) with metal coils during EVAR to prevent T2EL in patients at high risk. Methods Over a 24-month recruitment period, a total of 100 patients undergoing EVAR in four vascular centres (i.e. Klinikum rechts der Isar of the Technical University of Munich, University Hospital Augsburg, University Hospital Dresden, St. Joseph’s Hospital Wiesbaden) are to be included in the present study. Patients at high risk for T2EL (i.e. ≥ 5 efferent vessels covered by endograft or aneurysmal thrombus volume
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