Secondary Rupture of Aortic Aneurysm Post EVAR

Aortic Aneurysm Clinical Trial

Official title:

Secondary Rupture of Aortic Aneurysm After EVAR Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04507334
• Other study ID #: ID-RCB/EUDRACT
• Status: Not yet recruiting
• Start date: August 15, 2020
• Est. completion date: September 2020

Study information

• Verified date: August 2020
• Source: Central Hospital, Nancy, France
• Contact: camille salomon
• Phone: 0688027932
• Email: salomoncamille[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Rupture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

References & Publications (7)

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. — View 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. Review. — View 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. — View 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. Erratum in: Br J Surg. 2018 Aug;105(9):1222. — View Citation

Schlösser 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	describe survival in patient with secondary rupture aneurysm despite endovascular treatment	mortality describe in the group	20 years
Secondary	Compare survival in patients with rupture secondary aneurysm despite treatment	with endovascular according to: management of secondary rupture of the aneurysm; the hemodynamic state on arrival in the center treating; the size of the aneurysm sac	20 years
Secondary	2) Explore the risk factors for mortality in study patients		20 years