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

Endoprothesis Long-term Behavior After Subrenal Abdominal Aortic Aneurysm

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05072509

Acronym

COLONEA

Enrollment

180

Registered

2021-10-11

Start date

2022-02-01

Completion date

2025-11-01

Last updated

2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

Keywords

aortic, endovascular, aneurysm

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Reintervention rate	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
Lateral movement of the EVAR	through study completion, an average of 5 years	The lateral movement is defined by a movement of more than 5 mm.

Secondary

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

Countries

France

Outcome results