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NCT Number: NCT06975215

Pre-emptive Coil Embolization in Endovascular Aortic Repair

Abdominal aortic aneurysms are often treated with a minimally invasive procedure called endovascular aortic repair (EVAR). While EVAR is widely used, it can sometimes lead to complications over time, and some patients may require further procedures. One of the main issues is endoleak, which occurs when blood continues to flow into the aneurysm sac after treatment. This often happens because small nearby blood vessels, or other sources, continue to supply blood to the aneurysm.

A potentialy strategy to reduce the risk of endoleak is pre-emptive embolization-a technique used during EVAR to block these sources of persistent blood flow. This can include embolization of side branches, the aneurysm sac, or other contributing vessels. Early findings suggest that pre-emptive embolization may lower the risk of endoleaks, but it is still uncertain whether it improves long-term outcomes.

The PRIZE study (Randomized Controlled Trial on Pre-emptive Coil Embolization in Endovascular Aortic Repair) is designed to answer this question. In this research, patients are randomly assigned to one of two groups: one group will receive EVAR with pre-emptive embolization, and the other will receive EVAR without it.

Two main outcomes will be assessed. The first is aneurysm sac regression at two years, meaning a reduction in the size of the aneurysm sac after treatment. This is important because sac shrinkage after EVAR has been linked to lower overall mortality, even though the exact reasons for this are not yet fully understood. The second main outcome is the rate of aortic-related events over five years, as ensuring the long-term durability of treatment is a key goal of this study. Secondary outcomes, including quality of life, patient satisfaction, and cost-effectiveness will also be evaluated.

Currently, there is no clear agreement on whether pre-emptive embolization should be routinely used during EVAR. In a recent international survey, 76% of aortic specialists agreed that more evidence is needed. The PRIZE study aims to provide that evidence. If pre-emptive embolization proves effective, it could become a standard addition to EVAR, helping to improve both the immediate success and long-term durability of treatment. If not, the study will help avoid unnecessary procedures, ensuring patients receive only treatments that offer real benefits.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Abdominal aortic aneurysms with a maximum aortic diameter above the threshold for repair level.
  • High-risk criteria for type 2 endoleaks

Exclusion criteria

  • Does not fulfill instructions for use for standard EVAR
  • Contraindication for EVAR
  • Life expectancy less than 2 years

Treatment and study plan

Concomitant embolization

Device

This will include EVAR, following the standard pathway of care, associated with embolization. The decision to perform side-branch embolization or aneurysm sac embolization will be left to each participating centre/physician.

EVAR

Procedure

Endovascular aortic aneurysm repair

Primary outcomes

  1. Aneurysm sac regression at 2 years

    Time frame: 24 months

    Changes in the maximum aneurysm sac volume, which will be to assessed by an independent core lab.

  2. Rate of aortic events at 5 years

    Time frame: 60 months

    The number of study participants with aortic events, including:

    • Aortic-related reinterventions
    • Development of type I/III, with or without reintervention
    • Development of T2EL with sac expansion >10mm with or without reintervention
    • Graft infection
    • Aneurysm rupture
    • Aortic-related death

Study contacts

Contact information is provided by the study sponsor or research team.

Carlota F. Prendes, MD, PhD

CONTACT

[email protected]

+46729621501

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Pre-emptive Coil Embolization in Endovascular Aortic Repair: The PRIZE Study

Acronym: PRIZE

Important dates

Study start
2025
Primary completion
2030
Study completion
2033
First posted
May 16, 2025
Registry last updated
May 16, 2025

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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