Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents (ProxSim)

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery
• Intervention / Treatment: Other: Analyzed on the post-operative scanner

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Hôpital Louis Pradel
    • Contact: Antoine Millon, PU, PH; Phone Number: +33 04.72.11.11.16; Email: antoine.millon@chu-lyon.fr
    • Principal Investigator: Antoine Millon, PU, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Analyzed on the post-operative scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): August 15, 2023
• Study Completion (Estimated): September 15, 2023

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Endoprosthesis; numerical simulation; proximal neck
• Other Study ID Numbers: 69HCL23_0342

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No