I71.4
Conditions
Interventions
Group 1: Patients in the intervention group receive standard EVAR, in which a catheter is inserted into the aneurysm sac prior to stent graft implantation in order to perform coil embolization with at
Sponsors
Münchner Studienzentrum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Infrarenal AAA =50 mm maximum diameter - Indication for EVAR within IFU of company - Presence of one or both high risk criteria on CT-A: 1. =5 patent efferent vessels (inferior mesenteric and/or lumbar artery, and/or median sacral artery) 2. <40% thrombus at largest AAA diameter
Exclusion criteria
Exclusion criteria: - Ruptured AAA - Fenestrated/branched EVAR - Pregnancy - Concomitant iliac artery aneurysm - Non-ability to adhere to the FU protocol - Lack of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type II Endoleak at 12 months after procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| - T2EL proportions at time points 2-4 days, 30 days and 6 months after EVAR treatment, as measured by CEUS and/or CT-A - Rates of any re-intervention (for endoleaks, occlusions, graft infection, graft migration) - Occurrence of any EL Type I or III - Changes of AAA diameter and volume as measured by CT-A in comparison to initial CT-A scan at V0 - Rate of AAA rupture 12 months after EVAR treatment - Mortality (aneurysm-related/not aneurysm related) 12 months after EVAR treatment - Change in quality of life assessed by SF-36 from baseline to 12 months after EVAR treatment | — |
Countries
Germany
Contacts
Public ContactWissenschaftssekretariat Studienkoordination
Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie TUM Klinikum Rechts der Isar
Outcome results
None listed