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Clinical Trials/NCT05072509
NCT05072509Not yet recruitingNot Applicable

Endoprothesis Long-term Behavior After Subrenal Abdominal Aortic Aneurysm

Centre Hospitalier Universitaire de Besancon1 site in 1 country180 target enrollmentStarted: February 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
180
Locations
1
Primary Endpoint
Lateral movement of the EVAR

Study Overview

Brief Summary

The strength of movement which are applied on the EVAR are not only cranio-caudal but also lateral. The movement of the EVAR's body within the aneurysm could be an instability's criteria of the EVAR. The investigators would like to show that this lateral movement is a risk factor of reintervention they should follow and suggest a reinforced medical follow-up to avoid complications.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female > 18 years old
  • All patients treated in the vascular surgery department of Besançon for an abdominal aortic aneurysm with an endoprothesis (symptomatic or asymptomatic)

Exclusion Criteria

  • Patient in emergency situation (ruptured abdominal aortic aneurysm)
  • Life expectancy supposed to be inferior to 1 year
  • Legal incapacity or limited capacity
  • Pregnant female
  • Patient unlikely to cooperate with the study
  • Patient without health insurance

Outcomes

Primary Outcomes

Lateral movement of the EVAR

Time Frame: through study completion, an average of 5 years

The lateral movement is defined by a movement of more than 5 mm.

Reintervention rate

Time Frame: through study completion, an average of 5 years

For the the reintervention rate, all the intervention relative to a failure of the EVAR will be taken in account: as - Endoleak - Thrombosis - Conversion to open surgery - Infection - Secondary rupture

Secondary Outcomes

  • EVAR's movements: other than lateral.(1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.)
  • Compliance(1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.)
  • Moving(1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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