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

January 18, 2022 updated by: Centre Hospitalier Universitaire de Besancon

Endoprothesis Long-term Behavior After Subrenal Abdominal Aortic Aneurysm

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 Overview

Status

Not yet recruiting

Conditions

Abdominal Aortic Aneurysm

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Besançon, France, 25000
    - Vascular Surgery Department
    - Contact:
      
      Soumia SEBAIHI
      
      Phone Number: +33 0381218157
      
      Email: ssebaihi@chu-besancon.fr
    - Principal Investigator:
      
      Lucie Salomon Du Mont

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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)

Description

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

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

Observational Models: Cohort
Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 5 years
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.	through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EVAR's movements: other than lateral. Time Frame: 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.	Other than lateral	1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.
Moving Time Frame: 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.	EVAR's movement in relation to distal or proximal anchorage zones	1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.
Compliance Time Frame: 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.	The number of CT scanner compared to the number recommended by the Haute Autorité de Santé (HAS)	1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Association Le Don du Souffle

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)

February 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

October 8, 2021

First Posted (Actual)

October 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

2021-598

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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.