ProxSim: Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT05944835

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Other: Analyzed on the post-operative scanner

Study Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents

Actual Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Aug 15, 2023

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Louis Pradel	Bron		France	69500

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT05944835

Other Study ID Numbers:

69HCL23_0342

First Posted:

Jul 13, 2023

Last Update Posted:

Jul 13, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

Endoprosthesis

proximal neck

numerical simulation

Study Results

No Results Posted as of Jul 13, 2023