Validation of Fenestrations Positioning by Numerical Simulation
- Conditions
- Abdominal Aortic Aneurysms
- Interventions
- Other: numerical simulation
- Registration Number
- NCT03469245
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- abdominal aortic aneurysms suitable for treatment using Fenestrated AnacondaTM (Vascutek) device
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description abdominal aortic aneurysms treated by fenestrated endovascular numerical simulation Patients have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included. Predisurge society will perform numerical simulation.
- Primary Outcome Measures
Name Time Method Vascutek in vitro validation test and the numerical simulation 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 Outcome Measures
Name Time Method initial and final stent-graft designs obtained from Vascutek Months: 18 To study differences between initial and final stent-graft designs obtained from Vascutek process, the differences between L2 and L1 and C2 to C1 will be computed:
L = for each fenestration, the longitudinal distance between centre of fenestration and top of fabric C = for each fenestration, circumferential angular distance between O° line and center of fenestration
Current Vascutek protocol:
* Initial custom Stent Graft design, right before in vitro testing = L1 and C1
* Final custom Stent Graft design, after in vitro tests and subsequent design changes =L2 and C2stent-graft designs obtained from simulation of deployment Months: 18 To study differences between stent-graft designs obtained from simulation of deployment in the polymer model and from simulation of deployment in the patient, the differences between L4 and L3 and C4 to C3 will be computed:
L = for each fenestration, the longitudinal distance between centre of fenestration and top of fabric C = for each fenestration, circumferential angular distance between O° line and center of fenestration
Simulation for fenestration positioning:
* Initial custom Stent Graft design, right before in vitro testing = L3 and C3
* Final custom Stent Graft design, after in vitro tests and subsequent design changes =L4 and C4
Trial Locations
- Locations (9)
Wilhelminen hospital
🇦🇹Vienna, Austria
University Hospital Utrecht
🇳🇱Utrecht, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Derby Hospital
🇬🇧Derby, United Kingdom
CHU Bordeaux
🇫🇷Bordeaux, France
CHU Lyon
🇫🇷Lyon, France
Hôpitaux privés de Metz
🇫🇷Metz, France
University Hospital, Campus Benjamin Franklin
🇩🇪Berlin, Germany
Chu Saint-Etienne
🇫🇷Saint-Étienne, France