Clinical trial NCT05665101: EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)
Official title: EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)- A Randomized Controlled Multicentre Study in Germany
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Endoleak
Keywords: Abdominal Aortic Aneurysm
Endoleak
Endovascular aortic aneurysm repair
Coiling
Endoleak Type II
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: St. Josefs-Hospital Wiesbaden GmbH
name: University Hospital Augsburg
name: University Hospital Carl Gustav Carus
First posted: 2022-12-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Type II Endoleak at 12 months after procedure
timeFrame: 12 months
Secondary outcomes:
measure: Type II Endoleak during follow up
timeFrame: 2-4 days
measure: Type II Endoleak during follow up
timeFrame: 30 days
measure: Type II Endoleak during follow up
timeFrame: 6 months
measure: Re-intervention
timeFrame: 12 months
measure: Type I or III Endoleak
timeFrame: 12 months
measure: AAA morphology
timeFrame: 12 months
measure: AAA morphology
timeFrame: 12 months
measure: AAA rupture
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: life quality
timeFrame: 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie
state: Bayern
Study officials:
affiliation: Technical University Munich
name: Hans-Henning Eckstein, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: