Analysis of Respiration-induced Deformations in Visceral and Renal Arteries Before and After Stenting During Branched Stent Treatment. (BEVAR)
Primary Purpose
Complex Aortic Aneurysms
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Angioscan
Sponsored by
About this trial
This is an interventional treatment trial for Complex Aortic Aneurysms
Eligibility Criteria
Inclusion Criteria:
- no contre indication for coroscanner
Exclusion Criteria:
- pregnant woman
- allergy to iodinated contrast media
- vulnerable people
Sites / Locations
- Hopital Marie LannelongueRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Protocol
Arm Description
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.
Outcomes
Primary Outcome Measures
Geometry of the visceral and renal branches
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
Full Information
NCT ID
NCT04991636
First Posted
July 28, 2021
Last Updated
July 28, 2021
Sponsor
Centre Chirurgical Marie Lannelongue
1. Study Identification
Unique Protocol Identification Number
NCT04991636
Brief Title
Analysis of Respiration-induced Deformations in Visceral and Renal Arteries Before and After Stenting During Branched Stent Treatment.
Acronym
BEVAR
Official Title
Analysis of Respiration-induced Deformations in Visceral and Renal Arteries Before and After Stenting During Branched Stent Treatment.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
July 7, 2023 (Anticipated)
Study Completion Date
September 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Aortic Aneurysms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Angioscan
Intervention Description
La procédure d'étude prévoit de prendre des images pendant une inspiration profonde ainsi que pendant une expiration profonde. Cette deuxième mesure ne nécessite pas l'administration d'une quantité supplémentaire de produit de contraste. Cependant, le temps d'exposition aux rayonnements ionisants est doublé. L'examen utilise une acquisition hélicoïdale en mode rapide. La durée de l'hélice est de l'ordre de 2 secondes en phase d'inspiration, puis il y a un délai de 5 secondes de machine (" demi-tour ") et à nouveau 2 secondes d'exposition en phase d'expiration, soit 4 secondes d'exposition effective aux rayonnements ionisants, le temps de la prise d'image et 9 secondes le temps total de l'examen. l'image et 9 secondes la durée totale de l'examen.
Primary Outcome Measure Information:
Title
Geometry of the visceral and renal branches
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
no contre indication for coroscanner
Exclusion Criteria:
pregnant woman
allergy to iodinated contrast media
vulnerable people
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justine Mougin
Phone
01.40.94.82.04
Email
j.mougin@ghpsj.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stephan HAULON, PR
Phone
01.40.94.22.97
Email
s.haulon@ghpsj.fr
Facility Information:
Facility Name
Hopital Marie Lannelongue
City
Le Plessis-Robinson
ZIP/Postal Code
92350
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan HAULON, Pr
Phone
+33140942297
Email
s.haulon@hml.fr
12. IPD Sharing Statement
Learn more about this trial
Analysis of Respiration-induced Deformations in Visceral and Renal Arteries Before and After Stenting During Branched Stent Treatment.
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