Status:
COMPLETED
Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac
Lead Sponsor:
Centre Chirurgical Marie Lannelongue
Collaborating Sponsors:
Institut Mutualiste Montsouris
Henri Mondor University Hospital
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Abdominal aortic aneurysms (AAAs) continue to be a leading cause of death in older age groups. In the 60-85 year-old population, AAA represents the 14th-leading cause of death. Federal funding through...
Detailed Description
Study Objectives: The purpose of the current study is to compare the level of endoleaks between group 1 and 2 at 1, 6, 12 and 24 months. Study Design Prospective interventional study, multicenter, o...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Carrying a sub-renal AAA with a diameter of at least 5 cm at a rate of growth or greater 1cm/an diameter (according to Haute Autorité de Santé (HAS) recommendations toE VAR treatment),
- Patients with high risk of type II endoleak (clouding of an aortic aneurysm sac by collateral branch), respondents with at least one of the following criteria on the scanner to be included:
- The presence of a pair of permeable lumbar arteries.
- The presence of a patent inferior mesenteric artery.
Exclusion
- Sub renal Collet \<10 mm
- Angulated \> 60 °
- No collateral arising from the aneurysmal sac
- Iliac aneurysms associated
- Ruptured AAA
- Pregnant Women
- Lack of consent
- Lack of social security
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01878240
Start Date
May 1 2013
End Date
May 1 2019
Last Update
January 22 2020
Active Locations (3)
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1
Hopital Henri Mondor - APHP
Créteil, Île-de-France Region, France, 94000
2
Centre Chirurgical MarieLannelongue
Le Plessis-Robinson, Île-de-France Region, France, 92350
3
Institut Mutualiste Montsouris
Paris, Île-de-France Region, France, 75014