Actively Recruiting
EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)
Led by Christoph Knappich · Updated on 2025-09-30
100
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
Sponsors
C
Christoph Knappich
Lead Sponsor
T
Technical University of Munich
Collaborating Sponsor
AI-Summary
What this Trial Is About
Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture. Secondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.
CONDITIONS
Official Title
EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Infrarenal abdominal aortic aneurysm with a maximum diameter of 50 mm or more
- Indication for EVAR within company instructions for use
- CT scan showing at least 5 patent efferent vessels (inferior mesenteric, lumbar, or median sacral artery) or less than 40% thrombus at largest aneurysm diameter
You will not qualify if you...
- Ruptured abdominal aortic aneurysm
- Use of fenestrated or branched EVAR
- Presence of iliac artery aneurysm
- Unable to follow the follow-up protocol
- Lack of consent to participate
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie
Munich, Bavaria, Germany, 81675
Actively Recruiting
Research Team
C
Christoph Knappich, PD Dr. med.
CONTACT
M
Marie Kristin Fritsche, Dr. rer. nat.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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