An interventional study of Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV and Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV in Endovascular, sponsored by Nantes University Hospital. Recruiting at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
Evaluation of the clinical and cost-effectiveness of a mobile hybrid room compared with current practice without mobile hybrid room and imaging fusion guidance, in a French multicentre clinical setting.
The hypothesis is that the use of a mobile hybrid room with an automated artificial intelligent image fusion system would directly benefit patients, health worker and health care system by reducing procedure time, patient and staff exposure to radiation, improve clinical success and reduce costs (requested by a fixed imaging system installation and increasing the number of patients). This will also improve the safety of these procedures for patient and staff, when a conventional hybrid room is not available
Multi-centre, patient- and observer-blinded, two-armed, parallel groups randomised controlled trial. 7 French University hospital will include 350 patients presenting with AAA or aorto iliac occlusive disease suitable for endovascular treatment, to either repair using standard X-ray fluoroscopy imaging alone (the current reference standard) or augmented with automated image fusion. The study will be conducted in real-world clinical settings and will focus on multiple providers to demonstrate the effect in the wider healthcare system.
The trial will be conducted in 7 centres in France over 24 months. 350 patients will be recruited over a 18 month period, with 3 months minimum follow-up. Every vascular surgeon will be trained to use properly the fusion system, and the first 5 patients of each center won't be included.
Radiation parameters (machine report, passive dosimeters), iodinated contrast, technical and clinical success at 30-d and 3 months, procedure time, fluoro time, and costs will be collected.
Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
digestive arteries, iliac branch).
patient undergoing endovascular aortic repair with fusion imaging system guidance
Procedure: Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV
patient undergoing endovascular aortic repair without fusion imaging system guidance (only with X-rays and roadmaping)
Procedure: Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV
Cydar-EV image fusion is a CE-marked medical device, which instead of a table-tacked overlay uses computer vision to fuse pre-procedural 3D images with intra-operative 2D fluoroscopy automatically and in real-time.
patients will be assigned either to an endovascular repair using standard X-ray fluoroscopy imaging alone (the current reference standard)
Cost consequence analysis associated with endovascular procedures performed using automatic imaging fusion guidance and conventional endovascular technique performed without image fusion guidance up to 30 days time horizon and a collective perspective.
To compare the costs and consequences associated with endovascular procedures performed using automatic imaging fusion guidance and conventional endovascular technique performed without image fusion guidance. Consequences are listed in the secondary endpoints. Cos twill be express in €.
Time frame: 18 month
X-ray dose per procedure
exposure parameters from the machine
Time frame: day 0
X-ray dose per procedure for the physician
exposure parameters from the dosimeter
Time frame: day 0
Contrast dose per procedure
Contrast dose used
Time frame: day 0
Length of ITU/HDU admission
Length of ITU/HDU admission
Time frame: 18 months
Technical success
defined as proximal and distal seal zone at least 10mm and no evidence of endoleak or revascularization success.
Time frame: day 0
Clinical success
defined as primary patency rate or endovascular exclusion of the aneurysm
Time frame: 1 month
30-day mortality
30-day mortality
Time frame: 30 days
Quality of life questionnaire
EQ-5D-5L assessement
Time frame: 30 days
cost-effectiveness
Net financial impact over 5 years of SHMA deployment (based on the 5-year projection and different different scenarios for the spread of the technology)
Time frame: 5 years
Plan to share: No
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Nantes University Hospital