Trial record 11 of 139 for:    Open Studies | "Aortic Aneurysm"

Enhanced Guidance for Endovascular Repair of Abdominal Aortic Aneurysm (AAA 2D/3D II)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborators:
Siemens AG
Canadian Institutes of Health Research (CIHR)
Queen Elizabeth II Health Sciences Centre
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01824654
First received: April 2, 2013
Last updated: April 4, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Aortic Aneurysm, Abdominal
Other: Validation of the new rigid registration software
Other: Validation of the new elastic registration software

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Endovascular Repair of Abdominal Aortic Aneurysm: Enhanced Guidance by Elastic Registration Between CT-Scanner and Fluoroscopy

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Clinical validation of the new rigid registration software [ Time Frame: Day 0: On the first DSA acquisition performed after insertion of the main body device (before correction) ] [ Designated as safety issue: No ]
    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.

  • Clinical validation of the new elastic registration software [ Time Frame: Day 0: On the first DSA acquisition performed after insertion of the main body delivery device (before correction) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rigid and Elastic registration softwares Other: Validation of the new rigid registration software
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.
Other: Validation of the new elastic registration software
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.

Detailed Description:

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a clinical indication for EVAR/FEVAR of AAA and meeting anatomic inclusion criteria on preoperative enhanced CT-scan compatible with an endovascular repair.
  • Willing and capable of providing informed consent

Exclusion Criteria:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824654

Contacts
Contact: Andrée Cliche, RN, M.Sc. 514-890-8000 ext 28212 andree.cliche.chum@ssss.gouv.qc.ca
Contact: Jennifer Satterthwaite, M.Sc. 514-890-8000 ext 23483 jennifer.satterthwaite.chum@ssss.gouv.qc.ca

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Science Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Christopher Lightfoot, MD    902-473-2018    cblightf@dal.ca   
Principal Investigator: Christopher Lightfoot, MD         
Canada, Quebec
Centre Hospitalier de l'université de Montréal Not yet recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Andrée Cliche, RN, M.Sc.    514-890-8000 ext 28212    andree.cliche.chum@ssss.gouv.qc.ca   
Contact: Jennifer Satterthwaite, M.Sc.    514-890-8000 ext 23483    jennifer.satterthwaite.chum@ssss.gouv.qc.ca   
Principal Investigator: Gilles Soulez, MD.M.Sc.         
Sub-Investigator: Guy Cloutier, PhD         
Sub-Investigator: Jacques DeGuise, PhD         
Sub-Investigator: Stéphane Elkoury, MD         
Sub-Investigator: Claude Kauffmann, PhD         
Sub-Investigator: An Tang, MD         
Sub-Investigator: Éric Therasse, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Siemens AG
Canadian Institutes of Health Research (CIHR)
Queen Elizabeth II Health Sciences Centre
Investigators
Study Director: Gilles Soulez, MD,MSc Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01824654     History of Changes
Other Study ID Numbers: CE12.333
Study First Received: April 2, 2013
Last Updated: April 4, 2013
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Aortic Aneurysm, Abdominal
Imaging, Three-Dimensional
Tomography Scanners, X-Ray Computed
Angiography, Digital Subtraction
Endovascular Procedures
Radiography, Interventional

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on October 01, 2014