Clinical Trials Directory

Trials / Completed

CompletedNCT04724863

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Centre Chirurgical Marie Lannelongue · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAngioscanThe study procedure foresees to take images during a deep breath as well as deep exhalation. This second measurement does not require the administration of an additional amount of contrast material. However, the exposure time to ionising radiation is doubled. The examination uses helical acquisition in fast mode. The duration of the helix is of the order of 2 seconds in the inspiration phase, then there is a delay of 5 seconds of machine time ("half-turn") and again 2 seconds of exposure in the expiration phase, i.e. 4 seconds of actual exposure to ionizing radiation, the time of image taking and 9 seconds the total time of the examination.

Timeline

Start date
2020-04-28
Primary completion
2020-10-21
Completion
2021-01-21
First posted
2021-01-26
Last updated
2021-01-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04724863. Inclusion in this directory is not an endorsement.