Evaluating a mobile hybrid room for vascular surgery
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Besançon, Besançon and 6 other locations) |
| Trial ID | NCT06590532 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients requiring emergency procedures or those undergoing associated surgical interventions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Besançon, Besançon and 6 other locations
- 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)
- Pr Blandine Maurel — Nantes, Nantes, France (Recruiting)
- Jean-Baptiste — Nice, Nice, France (Not_yet_recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.