WARRIORS trial and registry
Research type
Research Study
Full title
Women’s Aneurysm Research: Repair Immediately or Routine Surveillance, Trial and Registry
IRAS ID
341602
Contact name
Janet Powell
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
24CX8836, Documas
Duration of Study in the UK
8 years, 5 months, 30 days
Research 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 primary outcome of aneurysm-related mortality or rupture at 5 years and secondary outcome Quality Adjusted-Life-Years; Others include operative mortality and complications, anxiety, and cost-effectiveness. Quality-of-life and anxiety questionnaires and “standard-of-care” using routine data will be collected. The trial uses only fully licensed devices within their intended purpose but does not investigate the device itself.
The trial aims to progress health equity through provision of evidence for sex-specific clinical guidelines for AAA repair.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
24/NW/0265
Date of REC Opinion
15 Oct 2024
REC opinion
Further Information Favourable Opinion