Analysis of Respiration-induced Deformities of the Visceral and Renal Arteries Before and After Stenting

Not Applicable

Completed

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

• Registration Number: NCT04724863
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

Brief Summary

Fenestrated stents are used for the management of complex juxta-renal, para-renal or thoracoabdominal aneurysms in patients with high surgical risk and/or contraindicated for open surgery. These endovascular techniques have demonstrated their safety and efficacy, however, long-term follow-up CT scans remain essential for the detection of complications such as endo-leaks and restenosis/thrombosis of visceral and renal stents. The respiratory cycle might induce changes in the geometry and deformations of visceral and renal stents after complex aortic procedures. These could be detected by an adapted CT scan analysis by deep inhalation and deep exhalation acquisition carried out pre-operatively and post-operatively for monitoring of these same stents and screening for complications.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-10
• Study Start: 2020-04-28
• Primary Completion: 2020-10-21
• Status Verified: 2021-01
• Study Completion: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Last Update Submitted: 2021-01-21
• Study First Posted: 2021-01-26
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• 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.

Secondary Outcome Measures

Name	Time	Method
Endoleaks number	3 months
stenosis number	3 months

Trial Locations

Locations (1)

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