Enhanced Guidance for Endovascular Repair of Abdominal Aortic Aneurysm

NCT01824654 | Completed

• 1 other identifier: CE12.333
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Aortic Aneurysm, Abdominal

Keywords

Aortic Aneurysm, Abdominal; Imaging, Three-Dimensional; Tomography Scanners, X-Ray Computed; Angiography, Digital Subtraction; Endovascular Procedures; Radiography, Interventional

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Rigid and Elastic registration softwares

EXPERIMENTAL

Other: Validation of the new rigid registration software; Other: Validation of the new elastic registration software

Interventions

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.

Rigid and Elastic registration softwares

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.

Rigid and Elastic registration softwares

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and capable of providing informed consent

You may not qualify if:

• Contraindication to endovascular repair
• Creatinine clearance \< 30ml/min
• History of severe allergy to iodinated contrast (anaphylaxis, bronchospasm)
• Absence of recent previous thin-slice enhanced CT-scanner examination (stent planning based on MRI examination or non-enhanced CT examination).

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Siemens AG: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Queen Elizabeth II Health Sciences Centre: collaborator

Study Sites (2)

Queen Elizabeth II Health Science Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Centre Hospitalier de l'université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Gilles Soulez, MD,MSc

  Centre hospitalier de l'Université de Montréal (CHUM)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 5, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: July 20, 2018

Record last verified: 2016-09

Locations

CA (2)