Aortic Aneurysm, AbdominalAAA 2D/3D IINCT01824654
Enhanced Guidance for Endovascular Repair of Abdominal Aortic Aneurysm
A study testing Validation of the new rigid registration software and Validation of the new elastic registration software in people with Aortic Aneurysm, Abdominal, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Validation of the new rigid registration software and Validation of the new elastic registration software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2013to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, B3H 2Y9
Centre Hospitalier de l'université de Montréal
Montreal, Quebec, H2L 4M1
About this study
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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Validation of the new rigid registration software, Validation of the new elastic registration software
- Keywords
- Aortic Aneurysm, Abdominal, Imaging, Three-Dimensional, Tomography Scanners, X-Ray Computed, Angiography, Digital Subtraction, Endovascular Procedures, Radiography, Interventional
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of the new rigid registration softwareOther
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.
Validation of the new elastic registration softwareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rigid and Elastic registration softwares | Experimental | Not described Receives: Other: Validation of the new rigid registration software; Other: Validation of the new elastic registration software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0: On the first DSA acquisition performed after insertion of the main body delivery device (before correction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens AG, Canadian Institutes of Health Research (CIHR), Queen Elizabeth II Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Gilles Soulez, MD,MSc, Study director, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824654
- Sponsor's protocol ID
- CE12.333
- Acronym
- AAA 2D/3D II
- Status last verified
- Sep 2016
- First submitted
- 2 Apr 2013
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Repair of Abdominal Aortic Aneurysm: Enhanced Guidance by Elastic Registration Between CT-Scanner and Fluoroscopy
- ClinicalTrials.gov ID
- NCT01824654
- Acronym / sponsor ID
- AAA 2D/3D II / CE12.333
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- Aortic Aneurysm, Abdominal, Imaging, Three-Dimensional, Tomography Scanners, X-Ray Computed, Angiography, Digital Subtraction, Endovascular Procedures, Radiography, Interventional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Siemens AG, Canadian Institutes of Health Research (CIHR), Queen Elizabeth II Health Sciences Centre
- Study start
- Apr 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rigid and Elastic registration softwares | Experimental | Other: Validation of the new rigid registration software, Other: Validation of the new elastic registration software |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation of the new rigid registration softwareSeveral 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 | Rigid and Elastic registration softwares |
| Validation of the new elastic registration softwareThis 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. | Other | Rigid and Elastic registration softwares |
Primary outcome
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)
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Soulez, MD,MSc study director
Centre hospitalier de l'Université de Montréal (CHUM)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Validation of the new rigid registration software and Validation of the new elastic registration software in people with Aortic Aneurysm, Abdominal, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.