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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04991636
Acronym
BEVAR
Enrollment
15
Registered
2021-08-05
Start date
2021-07-07
Completion date
2023-09-07
Last updated
2021-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Aortic Aneurysms

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.

Interventions

PROCEDUREAngioscan

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.

Sponsors

Centre Chirurgical Marie Lannelongue
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* no contre indication for coroscanner

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Geometry of the visceral and renal branches1 dayAn 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.

Countries

France

Contacts

Primary ContactJustine Mougin
j.mougin@ghpsj.fr01.40.94.82.04
Backup ContactStephan HAULON, PR
s.haulon@ghpsj.fr01.40.94.22.97

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026