Aortic Aneurysm, Abdominal Clinical Trial
Official title:
Endovascular Repair of Abdominal Aortic Aneurysm: Enhanced Guidance by Elastic Registration Between CT-Scanner and Fluoroscopy
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:
1. Improvement and implementation of the current rigid registration software. In this
phase, several new features 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 patients
at CHUM Research center and Dalhousie University-QEII Health Sciences Centre.
2. Implementation of an elastic registration based on endovascular device segmentation and
center line corrections. The luminal path of the segmented lumen on preoperative CT-scan
will be aligned with the path of the endovascular devices, then an elastic deformation
of the aortic lumen and thrombus meshes generated from CT-scanner will be applied and
registered to fluoroscopic and DSA images. A workflow allowing a fast recognition and
segmentation of endovascular devices from one to three stereotaxic fluoroscopic views
will be implemented in the Leonardo workstation and tested off-line on the previous 20
patient database and also in-vitro in realistic phantoms.
3. Online validation of elastic registration: The best strategy as defined above will be
validated clinically on-line. The beta version will be tested in real time in 20
patients requiring SG procedures and compared to the prior cohort having EVAR/FEVAR
procedures with rigid registration. The accuracy of rigid and elastic registrations will
be compared in the two experimental groups.
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