Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents

NCT05944835 | Unknown

• 1 other identifier: 69HCL23_0342
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Endoprosthesis; proximal neck; numerical simulation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  through study completion, an average of 1 year

Study Arms (1)

Patient who has been treated for an aortoiliac aneurysm

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

Other: Analyzed on the post-operative scanner

Interventions

Analyzed on the post-operative scanner OTHER

Analyzed on the post-operative scanner

Patient who has been treated for an aortoiliac aneurysm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Louis Pradel

Bron, 69500, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 13, 2023
• Study Start: February 15, 2023
• Primary Completion: August 15, 2023
• Study Completion: December 15, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-07

Locations

FR (1)