Pre-emptive Coil Embolization in Endovascular Aortic Repair

NCT06975215 | Not Yet Recruiting DMC

• 1 other identifier: PRIZE
• Study Type: interventional
• Target: 332
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Abdominal Aneurysm; Endovascular Aortic Repair; Endoleak

Outcome Measures

Primary Outcomes (2)

• Aneurysm sac regression at 2 years

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

  24 months

• Rate of aortic events at 5 years

  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

  60 months

Study Arms (2)

EVAR

ACTIVE COMPARATOR

EVAR, as per standard of care

Procedure: EVAR

EVAR + embolization

EXPERIMENTAL

EVAR, as per standard of care, associated with concomitant embolization

Device: Concomitant embolization; Procedure: EVAR

Interventions

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 + embolization

EVAR PROCEDURE

Endovascular aortic aneurysm repair

EVAR; EVAR + embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Endoleak

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Carlota F. Prendes, MD, PhD

CONTACT

+46729621501; carlota.fernandez@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2033
• Last Updated: May 16, 2025

Record last verified: 2025-05