Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice
French Randomised Controlled Trial Investigating the Clinical and Cost-effectiveness Role of a Cloud-based, Artificial Intelligent Image Fusion System to Guide Endovascular Aortic Aneurysm Repair and Aorto Iliac Revascularisation.
Nantes University Hospital
350 participants
Dec 10, 2024
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria8
- Procedure carried out in an operating theatre equipped with a mobile operating theatre C-arm or a mobile planar or an old-generation fixed room with no image fusion available
- Surgeon trained in the use of image fusion
- Operator who has given their consent
- Endovascular management of an aorto-iliac artery disease or a sub-renal AAA using a sub-renal bifurcated stent graft
- Patient in possession of an angioscan less than 6 months old
- Patient of legal age who has given his/her consent
- Ionising radiation generator with up-to-date and validated quality control
- Participant affiliated to a Social Security scheme
Exclusion Criteria9
- First procedure with fusion for the previously trained surgeon.
- Procedure performed without an operating aid.
- Emergency procedure.
- Associated surgical procedure (femoropopliteal lesions, lesions of the renal or digestive arteries, iliac branch).
- digestive arteries, iliac branch).
- Patients with AAA that cannot be treated by a simple sub-renal endovascular approach simple endovascular approach (subrenal bifurcated stent graft)
- Aortic emergencies (ruptured AAA).
- Persons under guardianship, curatorship or safeguard of justice
- Pregnant or breast-feeding women.
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Interventions
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)
Locations(7)
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NCT06590532