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

NCT06394271 | Not Yet Recruiting DMC

• 1 other identifier: 24CX8836
• Study Type: interventional
• Target: 1,112
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

abdominal aortic aneurysm; women's health; intervention threshold; endovascular aneurysm repair

Outcome Measures

Primary Outcomes (1)

• Aneurysm-related mortality and rupture

  Death caused by the aneurysm or its treatment and non-fatal rupture. Aneurysm-related mortality will include any death within 30 days of AAA repair, death in hospital at beyond 30 days for the index admission for AAA repair and at the same time-points after reinterventions following the index AAA repair, and death from repair or rupture of a supra-renal or iliac aneurysm.

  To at least 5 years

Secondary Outcomes (1)

• Quality-Adjusted Life Years

  5 years

Other Outcomes (5)

• Anxiety

  5 years

• Major Adverse Cardiovascular events

  5 years

• Hospital costs

  5 years

Study Arms (2)

Early EVAR

EXPERIMENTAL

Endovascular aneurysm repair within 2 months of randomisation using any licensed infrarenal aortic endograft within the manufacturer's instructions for use.

Device: EVAR

Surveillance

NO INTERVENTION

Regular imaging surveillance (ultrasound or CT) of aneurysm diameter until the diameter reaches 5.5 cm, develops symptoms of impending rupture or ruptures. The delayed repair may be by any method.

Interventions

EVAR DEVICE

Catheter based insertion of aortic endograft via iliac or femoral arteries

Also known as: infrarenal aortic endograft

Early EVAR

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female sex
• age ≥50 years
• infra-renal abdominal aortic aneurysm with a maximum infrarenal aortic anterior-posterior diameter 4.0-5.4 cm, aneurysm, measured on ultrasonography or the centreline orthogonal diameter on Computed Tomography (CT) scan when this is the discovery imaging mode,
• Local assessment that arterial morphology is suitable for EVAR within manufacturer's IFU for any licensed infrarenal endograft, including those with concomitant common iliac aneurysm(s), provided the device is landed in the iliac arteries, without coverage of patent internal iliac arteries.
• Rockwood frailty score \<7.

You may not qualify if:

• Male sex
• aneurysm of the infrarenal aorta of \<4.0 or \>5.4cm
• infrarenal aneurysm not meeting IFU for any specific licensed endograft for standard EVAR
• inability to give informed consent
• previous abdominal aortic surgery
• age \<50 years
• concomitant thoracic aortic aneurysm of \>4.0cm diameter
• excessive frailty (Rockwood frailty score 7 or more)
• life expectancy \<2 years (in the opinion of the site principal investigator)
• severe contrast allergy not amenable to steroid/antihistamine pretreatment (e.g., anaphylaxis)
• those considered unlikely to comply with follow-up
• concomitant common iliac artery aneurysm unless: a) the arterial morphology is within the IFU for standard infrarenal EVAR; or b) the arterial morphology is suitable for a licensed iliac branch device; or c) the internal iliac artery is occluded and the stent limb can be landed in the external iliac artery without embolization of the internal iliac artery.
• There will be no patient excluded as a result of geographical location, disability, gender, marriage and civil partnership status, ethnicity, religion or belief, sexual orientation, socioeconomic status or access to health or social care.

Sponsors & Collaborators

• Imperial College London: lead
• University College, London: collaborator
• University of Leicester: collaborator
• St Georges University Hospital: collaborator
• University of Southern Denmark: collaborator

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Alison Halliday, FRCS

  University of London

  STUDY CHAIR

Central Study Contacts

Rebecca Ruiz

CONTACT

+44735250468; warriors@imperial.ac.uk

Anna-Louise Pouncey, MRCS, PhD

CONTACT

+447912651686; a.pouncey@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Endpoint adjudication committee will be blinded to randomisation allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Women will be randomised 1:! to either early endovascular aneurysm repair or to routine surveillance until the aneurysm diameter reaches 5.5 cm. Randomisation will be stratified by country, age ( below 76 years or older) and aneurysm diameter (4.0-4.9 cm and larger).

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 1, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): October 31, 2033
• Study Completion (Estimated): April 30, 2034
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Available on the trial website now
• Access Criteria: Website