Greek Study for Endovascular Repair of Ruptured Abdominal Aortic Aneuryms

Launched by KOSTANTINOS PAPAZOGLOU · Jul 9, 2020

Keywords

ClinConnect Summary

Ruptured abdominal aortic aneurysms (rAAAs) remain one of the most emergent medical events, with over 90% mortality if left untreated and a prevalence of a minimum 45 patients per 1000000 population. The 30 day mortality for emergency open repair has remained at around 50%, and there is no consistent improvement in the outcome of the open technique over time. Since its development, endovascular aneurysm repair (EVAR), has been increasingly used even in the emergency setting.

So far there have been 4 randomized controlled trials, comparing EVAR versus open repair for rAAA. The first was a s...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * All alive patients admitted with rAAA and have anatomic suitability for EVAR according to manufacturer's IFU. More accurately the anatomic criteria for the research study are :
• • Neck diameter \>17mm, \< 32mm
• • Angle between the suprarenal aorta and the juxtarenal aorta \<60 degrees
• • Angle between the juxtarenal aorta and the long axis of the aneurysm sac \<90 degrees
• • Neck length \>10mm
• • Neck length \<10mm down to 4mm with Heli-FX EndoAnchor system
• • Adequate aortic bifurcation diameter in case of a bifurcated graft
• • Bilateral Iliac luminal diameter \>7mm
• • The vascular surgeon in charge will make the ultimate decision on suitability. All consecutive rAAAs treated with Endurant will be collected to avoid selection bias. No other criteria (e.g, mental illness, dementia, old age, comorbidities) will be applied to decline treatment and inclusion to the protocol. The final inclusion criterion will be that any vascular surgeon participating in the research study, must have carried out a minimum of 20 EVAR procedures for asymptomatic/symptomatic AAA. Apart from the initial 6 centers more centers can be implemented in the research study in the future.
• • AAA rupture will be confirmed and defined with computed tomography angiography (CTA). Rupture will be rated as free intraperitoneal rupture (free rupture), definite contrast extravasation and haematoma around the aorta (retroperitoneal rupture) and haematoma surrounding the aorta without definite contrast leak (contained rupture)
• Exclusion Criteria:
• • Symptomatic non ruptured AAAs will not be included even when treated as emergencies. Thoracoabdominal aneurysms and aortic dissections will also be excluded from the research study. Juxtarenal ruptured AAA treated with standard EVAR without chimney technique, outside IFU will also be excluded from the research study.However all consecutive rAAAs in the participating centers will be collected in a screening CRF to understand if this relates to rEVAR applicability.