Status:
UNKNOWN
Greek Study for Endovascular Repair of Ruptured Abdominal Aortic Aneuryms
Lead Sponsor:
Kostantinos Papazoglou
Collaborating Sponsors:
Medtronic
Aristotle University Of Thessaloniki
Conditions:
Rupture, Aortic
Aneurysm, Abdominal Aortic
Eligibility:
All Genders
Brief Summary
This will be a non-randomized, prospective, observational multi-center research study. Its purpose will be to assess the mortality and outcome of EVAR in patients with rAAA. As mentioned in the introd...
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT04471181
Start Date
February 1 2020
End Date
February 1 2023
Last Update
August 26 2021
Active Locations (1)
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1
Ippokrateio General Hospital
Thessaloniki, Macedonia, Greece, 54642