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Clinical Trials/NCT04724863
NCT04724863
Completed
Not Applicable

Analysis of Respiration-induced Deformities of the Visceral and Renal Arteries Before and After Stenting for a Endovascular Aortic Repair Procedure Using a Fenestrated Prothesis

Centre Chirurgical Marie Lannelongue1 site in 1 country15 target enrollmentApril 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complex Aortic Aneurysms
Sponsor
Centre Chirurgical Marie Lannelongue
Enrollment
15
Locations
1
Primary Endpoint
Geometry of the visceral and renal branches
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 28, 2020
End Date
January 21, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • no contre indication for coroscanner

Exclusion Criteria

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

Outcomes

Primary Outcomes

Geometry of the visceral and renal branches

Time Frame: 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 Outcomes

  • Endoleaks number(3 months)
  • stenosis number(3 months)

Study Sites (1)

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