Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents

Active, not recruiting

• Conditions: Surgery
• Interventions: Other: Analyzed on the post-operative scanner

• Registration Number: NCT05944835
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Endoprosthesis treatment of aortic pathologies has become the reference in the vast majority of situations. The success of this treatment is conditioned by the choice of the endoprosthesis which must be as adapted as possible to the anatomy. This choice is currently based on manual geometric measurements performed on the preoperative scanner using conventional image processing software.

The morphological result of the implantation of the endoprosthesis in the aorta is obtained by a CT scan carried out postoperatively. This scanner makes it possible to define the positioning of the endoprosthesis, the apposition surfaces between the aorta and the endoprosthesis and to predict the long-term result.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-15
• Status Verified: 2023-07
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-13
• Primary Completion: 2023-08-15
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Any patient who has been treated for an aortoiliac aneurysm with a standard Medtronic Endurant aortic stent, standard Gore Excluder or conformable Gore Excluder

Exclusion Criteria

• Patient who has objected to the use of their data.
• No preoperative scanner available or insufficient injection quality
• Preoperative scanner with slice thickness greater than 3 mm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient who has been treated for an aortoiliac aneurysm	Analyzed on the post-operative scanner	Any patient who has been treated for an aortoiliac aneurysm with a standard Medtronic Endurant aortic stent, standard Gore Excluder or conformable Gore Excluder

Primary Outcome Measures

Name	Time	Method
The accuracy of numerical simulation to predict the deployment at the level of the proximal neck of different types of standard stents used for the treatment of an aortoiliac aneurysm.	through study completion, an average of 1 year	Wwill be evaluated by measuring the diameter and the position of the center of the first 3 simulated proximal stents will be compared to those of the real stents, analyzed on the post-operative scanner

Trial Locations

Locations (1)

Hôpital Louis Pradel; 🇫🇷 Bron, France