Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice

NARecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

December 10, 2024

Primary Completion Date

May 1, 2025

Study Completion Date

May 1, 2026

Conditions
Endovascular
Interventions
PROCEDURE

Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV

Cydar-EV image fusion is a CE-marked medical device, which instead of a table-tacked overlay uses computer vision to fuse pre-procedural 3D images with intra-operative 2D fluoroscopy automatically and in real-time.

PROCEDURE

Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV

patients will be assigned either to an endovascular repair using standard X-ray fluoroscopy imaging alone (the current reference standard)

Trial Locations (7)

25000

NOT_YET_RECRUITING

Rinckenbach, Besançon

29200

NOT_YET_RECRUITING

NASR, Brest

38000

NOT_YET_RECRUITING

Spear, Grenoble

44000

RECRUITING

Pr Blandine Maurel, Nantes

51100

NOT_YET_RECRUITING

Duprey, Reims

94000

NOT_YET_RECRUITING

El Batti, Créteil

06000

NOT_YET_RECRUITING

Jean-Baptiste, Nice

All Listed Sponsors
lead

Nantes University Hospital

OTHER