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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2023-09-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Complex Aortic Aneurysms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Protocol

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.

Group Type EXPERIMENTAL

Angioscan

Intervention Type PROCEDURE

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.

Interventions

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Angioscan

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.

Intervention Type PROCEDURE