Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents

Surgery Clinical Trial

— ProxSim  

Official title:

Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05944835
• Other study ID #: 69HCL23_0342
• Status: Active, not recruiting
• Start date: February 15, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: July 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Analyzed on the post-operative scanner
Analyzed on the post-operative scanner

Locations

Country	Name	City	State
France	Hôpital Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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