Assessment of the Endovascular Aortic Aneurysm Repair's (EVAR) Main Body Lateral Movement Impact on the Rate of Reintervention After AAA's Treatment

NCT05072509 | Unknown

• 1 other identifier: 2021-598
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

aortic; endovascular; aneurysm

Outcome Measures

Primary Outcomes (2)

• Reintervention rate

  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

  through study completion, an average of 5 years

• Lateral movement of the EVAR

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

  through study completion, an average of 5 years

Secondary Outcomes (3)

• EVAR's movements: other than lateral.

  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.

• Compliance

  1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated in the vascular surgery department of Besançon for an abdominal aortic aneurysm with an endoprothesis (symptomatic or asymptomatic)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Association Le Don du Souffle: collaborator

Study Sites (1)

Vascular Surgery Department

Besançon, 25000, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: October 11, 2021
• Study Start: February 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2025
• Last Updated: January 19, 2022

Record last verified: 2021-10

Locations

FR (1)