Status:
RECRUITING
Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice
Lead Sponsor:
Nantes University Hospital
Conditions:
Endovascular
Eligibility:
All Genders
18+ years
Phase:
NA
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 settin...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06590532
Start Date
December 10 2024
End Date
May 1 2026
Last Update
December 19 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Rinckenbach
Besançon, Besançon, France, 25000
2
NASR
Brest, Brest, France, 29200
3
El Batti
Créteil, Créteil, France, 94000
4
Spear
Grenoble, Grenoble, France, 38000