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Clinical Trials/NCT03469245
NCT03469245
Completed
Not Applicable

Validation of Fenestrations Positioning by Numerical Simulation in Fenestrated Endovascular Repair of Abdominal Aortic Aneurysms

Centre Hospitalier Universitaire de Saint Etienne9 sites in 5 countries50 target enrollmentApril 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Aortic Aneurysms
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
50
Locations
9
Primary Endpoint
Vascutek in vitro validation test and the numerical simulation
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks... The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

Detailed Description

The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time. The goal of this study is to compare fenestrations positioning obtained by two different processes, the actual one at Vascutek and the one by numerical simulation performed by Predisurge company.

Registry
clinicaltrials.gov
Start Date
April 26, 2018
End Date
September 22, 2019
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • abdominal aortic aneurysms suitable for treatment using Fenestrated AnacondaTM (Vascutek) device

Exclusion Criteria

  • failure to generate an adequate FE model of patient arteries (no preoperative multidetector contrast-enhanced CT-scan available, preoperative CT-scan slice thickness greater than 1mm, preoperative CT-scan with artifacts)
  • stent-graft setup implanted during the surgical procedure has been modified compared to preoperative planning
  • patient refusing to participate to the study

Outcomes

Primary Outcomes

Vascutek in vitro validation test and the numerical simulation

Time Frame: Months: 18

To compare Vascutek in vitro validation test and the numerical simulation (Predisurge). The proportion of fenestrations is less or equal to 2.5mm will be calculated.

Secondary Outcomes

  • initial and final stent-graft designs obtained from Vascutek(Months: 18)
  • stent-graft designs obtained from simulation of deployment(Months: 18)

Study Sites (9)

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