Analysis of Respiration-induced Deformations in Visceral and Renal Arteries Before and After Stenting During Branched Stent Treatment.

Not Applicable

• Conditions: Complex Aortic Aneurysms
• Interventions: Procedure: Angioscan

• Registration Number: NCT04991636
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

Brief Summary

Aneurysm of the abdominal aorta is defined by a loss of parallelism of the arterial wall. The main risk of this pathology is the rupture of the aneurysm which is life threatening and this risk increases with the size of the aneurysm. Connected stents allow the management of complex thoracoabdominal aneurysms in patients at high surgical risk and/or contraindicated for open surgery. These endovascular techniques have demonstrated their safety and efficacy, however, long-term CT follow-up remains essential to detect complications such as endo-leaks and restenosis/thrombosis of visceral and renal stents. The prognostic factors of these complications remain poorly elucidated. The type of stent to be used could be an explanation, however, no stent has been proven to be superior in this application to date. Data from the literature suggest an influence of stents on the aortic geometry and the arterial axes of the digestive tract during respiratory movements. The work of the Stanford vascular surgery team shows that the deformations and modifications of the geometry of these stents induced by the respiratory cycle could have a negative impact by migration, stenosis and thrombosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-07
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Last Update Submitted: 2021-07-28
• Study First Posted: 2021-08-05
• Last Update Posted: 2021-08-05
• Primary Completion: 2023-07-07
• Study Completion: 2023-09-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• no contre indication for coroscanner

Exclusion Criteria

• pregnant woman
• allergy to iodinated contrast media
• vulnerable people

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Protocol	Angioscan	Each patient agreeing to participate in the study will be distributed in the protocol group and will receive an angioscan according to the protocol in pre-operative and at the usual post-operative check-up within 3 months after the operation. The usual procedure, foresees an angioscanner with injection of contrast product and the measurement of the images is performed during a deep breath. In order to obtain a complete respiratory cycle, the study procedure foresees in addition to the usual procedure, an image measurement during a deep exhalation.

Primary Outcome Measures

Name	Time	Method
Geometry of the visceral and renal branches	1 day	An angioscanner will be performed with injection in inspiration and expiration (breathing cycle) before and after stent placement for a fenestrated aortic endografts After reconstruction of a 3D volume of the aorta and extraction of the central lines of the different target arteries, the angle of the different visceral and renal branches will be measured during the respiratory cycle (inspiration; expiration) and compared before and after stenting.

Trial Locations

Locations (1)

Hopital Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, France