Actively Recruiting
Led by Christoph Knappich · Updated on 2025-09-30
100
Participants Needed
1
Research Sites
25 weeks
Total Duration
C
Christoph Knappich
Lead Sponsor
T
Technical University of Munich
Collaborating Sponsor
Researchers are studying abdominal aortic aneurysm (AAA), a condition where the aorta swells and may need repair. They are evaluating whether adding coil embolization, a procedure that places metal coils into the aneurysm sac during endovascular aortic aneurysm repair (EVAR), can reduce the risk of a complication called type II endoleak (T2EL). T2EL happens when blood continues to flow into the aneurysm through small vessels, which can lead to aneurysm growth or rupture. This randomized controlled multicenter study aims to see if coil embolization helps prevent T2EL after EVAR. Participants are randomly assigned to one of two groups: one group will receive standard EVAR along with coil embolization of the aneurysm sac, while the other group will receive standard EVAR without coil embolization. The specific type of coils used is not predefined. The study compares these two approaches to monitor their effect on preventing T2EL over time. During the study, participants will be followed and examined at several points, including 2 to 4 days, 30 days, 6 months, and 12 months after the procedure. Researchers will assess the presence of type II endoleak and other types of endoleaks, aneurysm morphology, need for re-intervention, aneurysm rupture, mortality, and quality of life. The primary outcome is the occurrence of type II endoleak at 12 months. The study ensures close monitoring and follow-up to understand the benefits and risks of adding coil embolization to EVAR.
CONDITIONS
EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure day
Participants undergo endovascular aortic repair (EVAR). Those in the experimental arm receive additional coil embolization of the aneurysm sac.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored for type II endoleaks and other outcomes following the procedure.
Visits at 2 to 4 days, 30 days, 6 months, and 12 months post-procedure
Total: 1 location
1
TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie
Munich, Bavaria, Germany, 81675
Actively Recruiting
C
Christoph Knappich, PD Dr. med.
M
Marie Kristin Fritsche, Dr. rer. nat.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Christoph Knappich, Felix Kirchhoff, Marie-Kristin Fritsche...
https://pubmed.ncbi.nlm.nih.gov/38167068