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Clinical Trials/NCT05944835
NCT05944835
Active, not recruiting
Not Applicable

Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents

Hospices Civils de Lyon1 site in 1 country15 target enrollmentFebruary 15, 2023
ConditionsSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Hospices Civils de Lyon
Enrollment
15
Locations
1
Primary Endpoint
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.
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2023
End Date
December 15, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: 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

Study Sites (1)

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