MedTrace Logo

Early Endovascular Repair Versus Surveillance for Women With Small Abdominal Aortic Aneurysm

NCT06394271 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1112

Last updated 2025-03-20

No results posted yet for this study

Summary

Elective Abdominal Aortic Aneurysm (AAA) repair is offered when the risk of rupture exceeds the risk of surgery. Women (versus men) have a four-fold higher risk of AAA rupture but almost double the operative mortality. It is unknown whether the current 5.5cm diameter AAA repair threshold, derived from randomised trials including only 4% women, is applicable to women.

Therefore, should women have their aneurysms repaired electively at smaller diameters than men to improve their AAA-related survival and quality of life? WARRIORS is an international randomised controlled trial of early elective endovascular repair versus routine surveillance in women (n=1112) with small asymptomatic AAA (4-5.4cm diameter), nested within a registry of non-participants. The surveillance group will be offered repair for rupture or upon reaching the 5.5cm threshold. Randomisation will be 1:1 stratified by country, age, and aneurysm diameter. The trial is powered for aneurysm-related mortality or rupture at 5 years. Quality-Adjusted-Life-Years is a major secondary outcome. Other outcomes include: operative mortality and complications, anxiety, major cardiovascular adverse events, and cost-effectiveness. Quality-of-life and anxiety questionnaires and "standard-of-care" using routine data will be collected.

The trial aims to progress health equity through provision of evidence for sex-specific clinical guidelines for AAA repair.

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DEVICE

EVAR

Catheter based insertion of aortic endograft via iliac or femoral arteries

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • University of Leicester

    collaborator OTHER

  • St Georges University Hospital

    collaborator UNKNOWN

  • University of Southern Denmark

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Alison Halliday, FRCS · University of London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2033-10-31
Completion
2034-04-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06394271 on ClinicalTrials.gov