IOPS Technology During Cannnulation of Contralateral Limb in EVAR

Not yet recruitingOBSERVATIONAL
Enrollment

80

Participants

Timeline

Start Date

January 20, 2025

Primary Completion Date

September 8, 2025

Study Completion Date

November 3, 2025

Conditions
Abdominal Aortic AneurysmAbdominal Aortic Aneurysm Without RuptureRadiation Exposure
Interventions
DEVICE

Intra-Operative Positioning System (IOPS)

This medical device provides surgeons with 3D visualization for increased surgical precision while reducing the use of contrast dye and radiation exposure for patients and healthcare professionals alike. IOPS provides 3D electromagnetic navigation of interventional devices as an adjunct to fluoroscopy. During the intervention, the IOPS devices can be visualized with on-screen image guidance. The console is operated by a technician under a physician's instruction. The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0.035-inch catheters and guidewires, as needed.

DEVICE

Conventional group

This group will be treated using standardised materials (wires, catheters) during EVAR.

Trial Locations (1)

11000

Clinical Center of Serbia, Belgrade

Sponsors
All Listed Sponsors
collaborator

Centerline Biomedical, Inc.

INDUSTRY

lead

Clinical Centre of Serbia

OTHER