Preventing Type II Endoleaks in Aortic Aneurysm Repair
EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)- A Randomized Controlled Multicentre Study in Germany
This study is testing if using metal coils during aortic aneurysm repair can help prevent type II endoleaks in patients with abdominal aortic aneurysms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT05665101 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of coil embolization in the aneurysm sac during endovascular aortic aneurysm repair (EVAR) to prevent type II endoleaks (T2EL), which can lead to complications such as aneurysm growth or rupture. Patients with infrarenal abdominal aortic aneurysms (AAA) that meet specific criteria will be enrolled to assess the efficacy of this intervention. The study aims to determine if deploying metal coils can effectively reduce the risk of T2EL in high-risk patients. By identifying risk factors for T2EL, the study seeks to improve outcomes for patients undergoing EVAR.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with infrarenal AAA of 50 mm or greater and specific high-risk criteria identified through CT imaging.
Not a fit: Patients with ruptured AAA, those requiring fenestrated or branched EVAR, or individuals unable to comply with follow-up protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of type II endoleaks and associated complications in patients undergoing EVAR.
How similar studies have performed: While the approach of coil embolization is being explored, the specific application in preventing T2EL during EVAR is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Ruptured AAA * Fenestrated or branched EVAR * Concomitant iliac artery aneurysm * Non-ability to adhere to the FU protocol * Lack of consent * Pregnancy
Where this trial is running
Munich, Bavaria
- TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie — Munich, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Christoph Knappich, PD Dr. med. — Technical University Munich
- Study coordinator: Christoph Knappich, PD Dr. med.
- Email: christoph.knappich@mri.tum.de
- Phone: 0049-894140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.