Abdominal aortic aneurysm Swelling of the main artery in the abdomen
Conditions
Interventions
Endovascular Aneurysm Repair (EVAR) 
Sponsors
Imperial College London
Eligibility
Age
18 Years to 99 Years
Inclusion 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; Local assessment that arterial morphology is suitable for EVAR; Rockwood frailty score <7.
Exclusion criteria
Exclusion criteria: Male sex; Aneurysm of the infrarenal aorta of <4.0 or >5.4cm; Infrarenal aneurysm not meeting Instructions For Use (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 score =7); Life expectancy <2 years in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of AAA rupture and aneurysm-related mortality at 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint: QALYs at 5 years (from quality of life and all-cause mortality).Other endpoints: Operative mortality Anxiety Costs Cost-effectiveness •Loss of eligibility for EVAR at the 5.5 cm diameter threshold Major adverse cardiovascular events (MACE), comprising myocardial infarction, stroke and lower limb amputation | — |
Countries
Australia, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, New Zealand, Portugal, Serbia, Sweden, United Kingdom, United States
Contacts
Public ContactJ.L. De Bruin
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed