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Active, not recruiting

NCT Number: NCT05665101

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Endoleak Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coil embolization of aneurysm sac

Procedure

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

Primary outcomes

  1. Type II Endoleak at 12 months after procedure

    Time frame: 12 months

    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

Secondary outcomes

  1. Type II Endoleak during follow up

    Time frame: 2-4 days

    T2EL 2-4 days after EVAR treatment detected by CEUS and/or CT-A

  2. Type II Endoleak during follow up

    Time frame: 30 days

    T2EL 30 days after EVAR treatment detected by CEUS and/or CT-A

  3. Type II Endoleak during follow up

    Time frame: 6 months

    T2EL 6 months after EVAR treatment detected by CEUS and/or CT-A

  4. Re-intervention

    Time frame: 12 months

    Rates of any re-intervention (for endoleaks, occlusions, graft infection, graft migration)

  5. Type I or III Endoleak

    Time frame: 12 months

    Occurrence of any EL Type I or III

  6. AAA morphology

    Time frame: 12 months

    Changes of AAA diameter as measured by CT-A in comparison to initial CT-A scan at V0

  7. AAA morphology

    Time frame: 12 months

    Changes of AAA volume as measured by CT-A in comparison to initial CT-A scan at V0

  8. AAA rupture

    Time frame: 12 months

    Rate of AAA rupture 12 months after EVAR treatment

  9. Mortality

    Time frame: 12 months

    Mortality (aneurysm-related/not aneurysm related) 12 months after EVAR treatment

  10. life quality

    Time frame: 12 months

    Change in quality of life assessed by SF-36 from baseline to 12 months after EVAR treat-ment

Sponsors and collaborators

Lead sponsor

Univ.-Prof. Dr. Dr. med. Daniela Branzan

Other

Collaborators

  • St. Josefs-Hospital Wiesbaden GmbH
  • Technical University of Munich
  • University Hospital Augsburg
  • University Hospital Carl Gustav Carus

Registry information

Official study 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

Acronym: EVAR-SE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 27, 2022
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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