- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01824654
Enhanced Guidance for Endovascular Repair of Abdominal Aortic Aneurysm (AAA 2D/3D II)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 2Y9
- Queen Elizabeth II Health Science Centre
-
-
Quebec
-
Montreal, Quebec, Canada, H2L 4M1
- Centre Hospitalier de l'Universite de Montreal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rigid and Elastic registration softwares
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
Day 0: On the first DSA acquisition performed after insertion of the main body delivery device (before correction)
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Gilles Soulez, MD,MSc, Centre Hospitalier de l'Université de Montréal (CHUM)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE12.333
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aortic Aneurysm, Abdominal
-
Assistance Publique - Hôpitaux de ParisUnknownSmall Abdominal Aortic Aneurysm | Abdominal Aortic Aneurysm,France
-
Karolinska University HospitalEnrolling by invitationAneurysm | Aortic Aneurysm | Abdominal Aortic Aneurysm, Ruptured | Aneurysm Abdominal | Abdominal Aortic Aneurysm Without RuptureSweden
-
EndologixActive, not recruiting1 Paravisceral Abdominal Aortic Aneurysm | 2 Juxtarenal Abdominal Aortic Aneurysm | 3 Pararenal Abdominal Aortic Aneurysm | 4 Complex Abdominal Aortic AneurysmsUnited States
-
Medtronic CardiovascularCompletedAbdominal Aortic Aneurysms (AAA)United States
-
Vascutek Ltd.TerminatedAbdominal Aortic Aneurysms (AAA)United Kingdom, Netherlands, Switzerland, Spain, Germany, Belgium, Sweden, Canada, France, Italy, Austria, Monaco
-
Timothy Chuter, MDRecruitingThoracoabdominal Aortic Aneurysm | Paravisceral Abdominal Aortic AneurysmUnited States
-
Washington University School of MedicineRecruitingAbdominal Aortic Aneurysm (AAA) | No Abdominal Aortic Aneurysm (Non-AAA)United States
-
University of California, San DiegoRecruitingJuxtarenal Aortic Aneurysm | Thoracoabdominal Aortic Aneurysm | Pararenal Aortic Aneurysm | Complex Abdominal Aortic AneurysmUnited States
-
Assistance Publique Hopitaux De MarseilleCompletedAbdominal Aortic AneurysmsFrance
-
Hangzhou Endonom Medtech Co., Ltd.RecruitingJuxtarenal Abdominal Aortic AneurysmChina
Clinical Trials on Validation of the new rigid registration software
-
Zurich University of Applied SciencesUniversitat Politècnica de ValènciaCompletedPrevention Harmful Effects
-
Ente Ospedaliero Cantonale, BellinzonaNeurocenter of Southern Switzerland; Istituto Cantonale di PatologiaRecruiting
-
Yonsei UniversityWithdrawn
-
Centre Hospitalier Universitaire de NiceRecruitingFacioscapulohumeral Muscular Dystrophy Type 2France, Italy, Spain
-
Centre Hospitalier Universitaire de NiceActive, not recruitingMuscular Dystrophy | FacioscapulohumeralFrance
-
Medela AGCompleted
-
Kerckhoff KlinikHannover Medical School; University Hospital, SaarlandUnknownChronic Thromboembolic Pulmonary Hypertension | CTEPHGermany
-
Centre Hospitalier Universitaire de NiceRecruitingFacioscapulohumeral Muscular DystrophyFrance
-
Institut National de la Santé Et de la Recherche...Enrolling by invitationCharacterization of New Candidate Genes in Cases of Human Inherited Thrombocytopenia (CATCH) (CATCH)Thrombocytopenia | Inherited Platelet DisorderFrance
-
Vastra Gotaland RegionSahlgrenska University Hospital, Sweden; The Göteborg Medical Society, SwedenCompletedEsophageal Cancer | Dysphagia, EsophagealSweden