NCT04507334

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

17 days

First QC Date

August 7, 2020

Last Update Submit

August 7, 2020

Conditions

Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • describe survival in patient with secondary rupture aneurysm despite endovascular treatment

    mortality describe in the group

    20 years

Secondary Outcomes (2)

  • Compare survival in patients with rupture secondary aneurysm despite treatment

    20 years

  • 2) Explore the risk factors for mortality in study patients

    20 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with ruptured aortic aneurysm + EVAR

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 19008129BACKGROUND

  • 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.

    PMID: 28160528BACKGROUND

  • 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.

    PMID: 21037436BACKGROUND

  • 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.

    PMID: 9685145BACKGROUND

  • 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.

    PMID: 9685144BACKGROUND

  • 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.

    PMID: 14532875BACKGROUND

  • 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.

    PMID: 12042725BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Central Study Contacts

camille salomon

CONTACT

0688027932salomoncamille@gmail.com

Serguei Malikov

CONTACT

0679322495s.malikov@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 11, 2020

Study Start

August 15, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

August 11, 2020

Record last verified: 2020-08