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| Name | Class |
|---|---|
| Predisurge Society | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abdominal aortic aneurysms treated by fenestrated endovascular | Patients have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included. Predisurge society will perform numerical simulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| numerical simulation | Other | After patients have been treated by fenestrated endovascular of society Vascutek data will be collected by society Vascutek and send to Predisurge society. They will perform numerical simulation and compare with the method of Vascutek. |
| Measure | Description | Time Frame |
|---|---|---|
| Vascutek in vitro validation test and the numerical simulation | 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. | Months: 18 |
| Measure | Description | Time Frame |
|---|---|---|
| initial and final stent-graft designs obtained from Vascutek | 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:
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Inclusion Criteria:
- abdominal aortic aneurysms suitable for treatment using Fenestrated AnacondaTM (Vascutek) device
Exclusion Criteria:
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Patients have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Bertrand CHAVENT, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilhelminen hospital | Vienna | Austria | ||||
| CHU Bordeaux |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Months: 18 |
| stent-graft designs obtained from simulation of deployment | 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:
| Months: 18 |
| Bordeaux |
| France |
| CHU Lyon | Lyon | France |
| Hôpitaux privés de Metz | Metz | France |
| Chu Saint-Etienne | Saint-Etienne | France |
| University Hospital, Campus Benjamin Franklin | Berlin | Germany |
| Rijnstate Hospital | Arnhem | Netherlands |
| University Hospital Utrecht | Utrecht | Netherlands |
| Derby Hospital | Derby | United Kingdom |
| D001018 |
| Aortic Diseases |