Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice
- Conditions
- Endovascular
- Interventions
- Procedure: Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EVProcedure: Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV
- Registration Number
- NCT06590532
- Lead Sponsor
- Nantes University Hospital
- Brief 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fusion group Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV patient undergoing endovascular aortic repair with fusion imaging system guidance Control group Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV patient undergoing endovascular aortic repair without fusion imaging system guidance (only with X-rays and roadmaping)
- Primary Outcome Measures
Name Time Method 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. 18 month 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 €.
- Secondary Outcome Measures
Name Time Method X-ray dose per procedure day 0 exposure parameters from the machine
X-ray dose per procedure for the physician day 0 exposure parameters from the dosimeter
Contrast dose per procedure day 0 Contrast dose used
Length of ITU/HDU admission 18 months Length of ITU/HDU admission
Technical success day 0 defined as proximal and distal seal zone at least 10mm and no evidence of endoleak or revascularization success.
Clinical success 1 month defined as primary patency rate or endovascular exclusion of the aneurysm
30-day mortality 30 days 30-day mortality
Quality of life questionnaire 30 days EQ-5D-5L assessement
cost-effectiveness 5 years 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)
Trial Locations
- Locations (7)
Rinckenbach
🇫🇷Besançon, France
Pr Blandine Maurel
🇫🇷Nantes, France
NASR
🇫🇷Brest, France
El Batti
🇫🇷Créteil, France
Spear
🇫🇷Grenoble, France
Jean-Baptiste
🇫🇷Nice, France
Duprey
🇫🇷Reims, France