EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)

Abdominal Aortic Aneurysm Clinical Trial

— EVAR-SE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665101
• Other study ID #: V1.1
• Secondary ID: 01KG2128
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2023
• Source: Technical University of Munich
• Contact: Hans-Henning Eckstein, MD,PhD
• Phone: 0049-894140
• Email: gefaesschirurgie[@]mri.tum.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Endoleak

Intervention

Procedure:
• Coil embolization of aneurysm sac
Patients are treated with standard EVAR with additional coiling of the aneurysm sac. The distinct type of coils used is not predefined.

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie	Munich	Bayern

Sponsors (5)

Lead Sponsor	Collaborator
Univ.-Prof. Dr. med. Hans-Henning Eckstein	St. Josefs-Hospital Wiesbaden GmbH, Technical University of Munich, University Hospital Augsburg, University Hospital Carl Gustav Carus

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type II Endoleak at 12 months after procedure	Evaluation of the T2EL proportion of the intervention group as compared to the control group at 12 months after EVAR treatment as measured by CEUS and/or CT-A	12 months
Secondary	Type II Endoleak during follow up	T2EL 2-4 days after EVAR treatment detected by CEUS and/or CT-A	2-4 days
Secondary	Type II Endoleak during follow up	T2EL 30 days after EVAR treatment detected by CEUS and/or CT-A	30 days
Secondary	Type II Endoleak during follow up	T2EL 6 months after EVAR treatment detected by CEUS and/or CT-A	6 months
Secondary	Re-intervention	Rates of any re-intervention (for endoleaks, occlusions, graft infection, graft migration)	12 months
Secondary	Type I or III Endoleak	Occurrence of any EL Type I or III	12 months
Secondary	AAA morphology	Changes of AAA diameter as measured by CT-A in comparison to initial CT-A scan at V0	12 months
Secondary	AAA morphology	Changes of AAA volume as measured by CT-A in comparison to initial CT-A scan at V0	12 months
Secondary	AAA rupture	Rate of AAA rupture 12 months after EVAR treatment	12 months
Secondary	Mortality	Mortality (aneurysm-related/not aneurysm related) 12 months after EVAR treatment	12 months
Secondary	life quality	Change in quality of life assessed by SF-36 from baseline to 12 months after EVAR treat-ment	12 months