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| Name | Class |
|---|---|
| Siemens AG | INDUSTRY |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Queen Elizabeth II Health Sciences Centre | OTHER |
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An increasing incidence of abdominal aortic aneurysms (AAA) is observed in our ageing population. Since it is less invasive, endovascular repair (EVAR) by stent-graft (SG) insertion is frequently indicated in patients with intermediate and high-operative risk. Patient selection and stent planning for EVAR is done on CT-scans based on specific anatomic criteria. SG are inserted in the catheterization laboratory under digital substraction angiography (DSA) and fluoroscopic guidance. With this technology, no soft-tissue differentiation is available during the intervention and important information are lacking such as thrombus and aneurysm extension close to proximal and distal landing zones. Our team has recently patented a software allowing the extraction of the AAA (lumen and thrombus) from pre-operative CT-scanner. In collaboration with Siemens medical, the investigators have integrated this technology to the Siemens workstation in the catheterization laboratory. The investigators can now import the aortic lumen and thrombus meshes segmented from pre-operative CT-scans and perform a rigid registration with fluoroscopy and DSA data to enhance visualization of soft tissue during EVAR.
Our preliminary results are encouraging in terms of feasibility and visualization. However, the delivery device of the SG and the guidewire used during the intervention are stiff and induce a deformation of aortic lumen and thrombus. This deformation impairs the accuracy of rigid registration. The investigators propose to improve registration accuracy by implementing an elastic deformation of aortic lumen and wall based on the segmentation of endovascular devices (delivery device, guidewires and catheters) inserted during the procedure and by biomechanical modeling.
This project has 3 objectives: 1. To implement and validate a new optimized workflow enabling rigid registration between AAA meshes extracted from preoperative CT-scan with fluoroscopic images. 2. To develop an elastic registration of the AAA meshes based on 2D or 3D modeling of the endovascular device. 3. To validate the accuracy of elastic registration and compare it with the rigid registration.
Experimental protocol: These 3 objectives will be completed in three experimental phases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rigid and Elastic registration softwares | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Validation of the new rigid registration software | Other | Several new features of this beta software such as an improved correction system by automatic capture of DSA, an automated 3D/3D rigid registration, recognition of the origin of internal iliac arteries will be implemented. This new beta version will be tested in 20 cases of EVAR/FEVAR at CHUM Research center and Dalhousie University-QEII Health Sciences Centre. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical validation of the new rigid registration software | The measure of the mean 2D error in the z axis (cranio-caudal direction) of the renal arteries marker positions on the first DSA acquisition performed after insertion of the main body delivery device (before correction). It will be measured after exportation of the video on the Leonardo screen overlaying DSA and rigid registration of AAA meshes and renal markers. | Day 0: On the first DSA acquisition performed after insertion of the main body device (before correction) |
| Clinical validation of the new elastic registration software | The measure of the mean 2D error of renal artery marker position (z direction) on the first DSA acquisition performed after insertion of the main body delivery device as describe in the clinical validation of the new rigid registration software. | Day 0: On the first DSA acquisition performed after insertion of the main body delivery device (before correction) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Soulez, MD,MSc | Centre hospitalier de l'Université de Montréal (CHUM) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth II Health Science Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada | ||
| Centre Hospitalier de l'université de Montréal |
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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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| Validation of the new elastic registration software | Other | This software integrating deformation of vasculature induced by insertion of endovascular devices will be tested in real time in 20 patients requiring SG procedures at CHUM Research center and Dalhousie University-QEII Health Sciences Centre and compared to the prior cohort having EVAR/FEVAR procedures with rigid registration. |
|
| Montreal |
| Quebec |
| H2L 4M1 |
| Canada |
| D001018 |
| Aortic Diseases |