Evaluating a mobile hybrid room for vascular surgery
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.
Run by Nantes University Hospital · NCT06590532 · Data updated 2026-11-12
This study is testing whether using a new mobile imaging system during vascular surgery can improve patient outcomes and reduce costs compared to standard X-ray methods for people with specific blood vessel conditions.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Besançon, Besançon and 6 other locations) |
| Status | Recruiting |
| Started | December 10, 2024 |
| Main results expected | May 1, 2025 |
| Study ends | May 1, 2026 |
| Registry record updated | December 19, 2024 |
| Trial ID | NCT06590532 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with aorto-iliac artery disease or abdominal aortic aneurysms who are eligible for endovascular treatment and have a recent angioscan.
✕Probably not a fit
Patients requiring emergency procedures or those undergoing associated surgical interventions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the clinical and cost-effectiveness of a mobile hybrid room equipped with an automated image fusion system compared to standard X-ray fluoroscopy imaging in vascular surgery. Conducted across seven French university hospitals, the study aims to recruit 350 patients with aorto-iliac occlusive disease or abdominal aortic aneurysms suitable for endovascular treatment. Participants will be randomly assigned to receive treatment with or without the advanced imaging system, with outcomes measured in terms of procedure time, radiation exposure, clinical success, and costs. The trial will be conducted in real-world settings to assess the broader impact on healthcare systems.
Why it matters
Potential benefit: If successful, this approach could enhance patient safety and reduce healthcare costs while improving clinical outcomes in vascular surgery.
How similar studies have gone: While the use of mobile hybrid rooms is gaining interest, this specific approach with automated image fusion is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where it's running
-
Pr Blandine Maurel
Nantes, Nantes, France Recruiting -
Rinckenbach
Besançon, Besançon, France Not yet recruiting -
Nasr
Brest, Brest, France Not yet recruiting -
El Batti
Créteil, Créteil, France Not yet recruiting -
Spear
Grenoble, Grenoble, France Not yet recruiting -
Jean-Baptiste
Nice, Nice, France Not yet recruiting
Show 1 more location
-
Duprey
Reims, Reims, France Not yet recruiting
Study contacts
- Study coordinator: Blandine Maurel, Pr
- Email: blandine.maurel@chu-nantes.fr
- Phone: 02 40 16 53 72
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.