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

• Published in: Current controlled trials in cardiovascular medicine 2024-01, Vol.25 (1), p.17-17, Article 17
• Main Authors: Knappich, Christoph, Kirchhoff, Felix, Fritsche, Marie-Kristin, Egert-Schwender, Silvia, Wendorff, Heiko, Kallmayer, Michael, Haller, Bernhard, Hyhlik-Duerr, Alexander, Reeps, Christian, Eckstein, Hans-Henning, Trenner, Matthias
• Format: Article
• Language: English
• Subjects: Abdominal aneurysm; Analysis; Aneurysms; Aortic aneurysm; Aortic Aneurysm, Abdominal - diagnostic imaging; Aortic Aneurysm, Abdominal - surgery; Blood clots; Blood Vessel Prosthesis Implantation - adverse effects; Care and treatment; Complications and side effects; CT imaging; Embolization; Embolization, Therapeutic - adverse effects; Endoleak; Endoleak - diagnostic imaging; Endoleak - etiology; Endoleak - prevention & control; Endovascular; Endovascular Aneurysm Repair; Endovascular Procedures - adverse effects; Heart valve replacement; Humans; Medical prognosis; Medical research; Medicine, Experimental; Mortality; Multicenter Studies as Topic; Patient outcomes; Patients; Prevention; Prospective studies; Quality of Life; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Factors; Study Protocol; Treatment Outcome; Ultrasonic imaging; Veins & arteries
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07888-8

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. 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