Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice
Key facts
- Who runs it
- Nantes University Hospital
- Where
- France7 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 350 people, planned
- Started
- 10 Dec 2024
- Planned end
- 1 May 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV
- Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV
- Record updated
- 19 December 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- First procedure with fusion for the previously trained surgeon
- Associated surgical procedure (femoropopliteal lesions, lesions of the renal or digestive arteries, iliac branch); digestive arteries, iliac branch)
- Procedure performed without an operating aid
- Emergency procedure
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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
The 2 groups in the trial
- Fusion groupTreatment being tested
patient undergoing endovascular aortic repair with fusion imaging system guidance
Treatment: Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV
- Control groupExisting treatment, for comparison
patient undergoing endovascular aortic repair without fusion imaging system guidance (only with X-rays and roadmaping)
Treatment: Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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.
- Record updated
- 19 December 2024