- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04507334
Secondary Rupture of Aortic Aneurysm Post EVAR
August 7, 2020 updated by: Central Hospital, Nancy, France
Secondary Rupture of Aortic Aneurysm After EVAR Management
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: camille salomon
- Phone Number: 0688027932
- Email: salomoncamille@gmail.com
Study Contact Backup
- Name: Serguei Malikov
- Phone Number: 0679322495
- Email: s.malikov@chru-nancy.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with ruptured aortic aneurysm + EVAR
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
describe survival in patient with secondary rupture aneurysm despite endovascular treatment
Time Frame: 20 years
|
mortality describe in the group
|
20 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare survival in patients with rupture secondary aneurysm despite treatment
Time Frame: 20 years
|
with endovascular according to:
|
20 years
|
2) Explore the risk factors for mortality in study patients
Time Frame: 20 years
|
20 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 15, 2020
Primary Completion (Anticipated)
September 1, 2020
Study Completion (Anticipated)
September 1, 2020
Study Registration Dates
First Submitted
August 7, 2020
First Submitted That Met QC Criteria
August 7, 2020
First Posted (Actual)
August 11, 2020
Study Record Updates
Last Update Posted (Actual)
August 11, 2020
Last Update Submitted That Met QC Criteria
August 7, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID-RCB/EUDRACT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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