Clinical trial NCT04507334: Secondary Rupture of Aortic Aneurysm Post EVAR
Official title: Secondary Rupture of Aortic Aneurysm After EVAR Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with ruptured aortic aneurysm + EVAR

Brief summary: Post-stent rupture of the abdominal aorta is a rare occurrence and with few publications: only 2 multicenter studies and one meta-analysis in 2017 listed this complication As well as a few cases reports This study, the first carried out in France, aims to describe the survival in patients with secondary rupture of the aneurysm despite initial treatment with EVAR.


Eligibility criteria: Inclusion Criteria:

* - Patient who had a ruptured aortic aneurysm between 01/01/1993 and 07/31/2020)
* Patients whose aortic aneurysm has been treated with EVAR

Exclusion Criteria:

* No

Primary outcomes:
measure: describe survival in patient with secondary rupture aneurysm despite endovascular treatment
timeFrame: 20 years
Secondary outcomes:
measure: Compare survival in patients with rupture secondary aneurysm despite treatment
timeFrame: 20 years
measure: 2) Explore the risk factors for mortality in study patients
timeFrame: 20 years
Other outcomes:
Locations:
Study officials:
References:
citation: Schlosser FJ, Gusberg RJ, Dardik A, Lin PH, Verhagen HJ, Moll FL, Muhs BE. Aneurysm rupture after EVAR: can the ultimate failure be predicted? Eur J Vasc Endovasc Surg. 2009 Jan;37(1):15-22. doi: 10.1016/j.ejvs.2008.10.011. Epub 2008 Nov 12.
citation: Powell JT, Sweeting MJ, Ulug P, Blankensteijn JD, Lederle FA, Becquemin JP, Greenhalgh RM; EVAR-1, DREAM, OVER and ACE Trialists. Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years. Br J Surg. 2017 Feb;104(3):166-178. doi: 10.1002/bjs.10430.
citation: Wyss TR, Brown LC, Powell JT, Greenhalgh RM. Rate and predictability of graft rupture after endovascular and open abdominal aortic aneurysm repair: data from the EVAR Trials. Ann Surg. 2010 Nov;252(5):805-12. doi: 10.1097/SLA.0b013e3181fcb44a.
citation: Torsello GB, Klenk E, Kasprzak B, Umscheid T. Rupture of abdominal aortic aneurysm previously treated by endovascular stentgraft. J Vasc Surg. 1998 Jul;28(1):184-7. doi: 10.1016/s0741-5214(98)70214-9.
citation: Alimi YS, Chakfe N, Rivoal E, Slimane KK, Valerio N, Riepe G, Kretz JG, Juhan C. Rupture of an abdominal aortic aneurysm after endovascular graft placement and aneurysm size reduction. J Vasc Surg. 1998 Jul;28(1):178-83. doi: 10.1016/s0741-5214(98)70213-7.
citation: Fransen GA, Vallabhaneni SR Sr, van Marrewijk CJ, Laheij RJ, Harris PL, Buth J; EUROSTAR. Rupture of infra-renal aortic aneurysm after endovascular repair: a series from EUROSTAR registry. Eur J Vasc Endovasc Surg. 2003 Nov;26(5):487-93. doi: 10.1016/s1078-5884(03)00350-2.
citation: Bernhard VM, Mitchell RS, Matsumura JS, Brewster DC, Decker M, Lamparello P, Raithel D, Collin J. Ruptured abdominal aortic aneurysm after endovascular repair. J Vasc Surg. 2002 Jun;35(6):1155-62. doi: 10.1067/mva.2002.123758.