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

Abdominal Aortic Aneurysm Clinical Trial

— COLONEA  

Official title:

Endoprothesis Long-term Behavior After Subrenal Abdominal Aortic Aneurysm

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05072509
• Other study ID #: 2021-598
• Status: Not yet recruiting
• Start date: February 1, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: October 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
France	Vascular Surgery Department	Besançon

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Association Le Don du Souffle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	EVAR's movements: other than lateral.	Other than lateral	1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.
Secondary	Moving	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.
Secondary	Compliance	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.