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

Launched by IMPERIAL COLLEGE LONDON · Apr 30, 2024

Keywords

ClinConnect Summary

The WARRIORS trial is studying whether women with small abdominal aortic aneurysms (AAAs) should have surgery earlier than the current standard, which is when the aneurysm reaches 5.5 centimeters in size. This is important because women face a higher risk of complications from AAA than men, but most research has focused on men. The trial will compare two groups: one group will have early surgery for their small aneurysms (between 4.0 and 5.4 cm), while the other group will be monitored and only receive surgery if their aneurysm grows bigger or if they experience a rupture.

To participate in this trial, women must be at least 50 years old and have a small AAA that meets certain size criteria. Participants can expect to be involved for about five years, during which they will receive regular check-ups and may complete surveys about their quality of life and anxiety. This study aims to provide better guidance for treating AAAs in women, ultimately helping to improve their health outcomes and quality of life. The trial is not yet recruiting, but it will include women from various backgrounds without excluding anyone based on geographic location or other personal factors.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.