3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair

NAActive, not recruitingINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

October 18, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Abdominal Aortic Aneurysm
Interventions
DEVICE

3D Holographic Guidance, Navigation, and Control (3D GN&C)

"Using electromagnetic (EM) guidance and tracking to precisely place a Cook Zenith Flex AAA bifurcated stent graft during EVAR. EM guidance and tracking is enabled using a system consisting of:~1. experimental 3D guidance, navigation, and control (3D-GNC) software developed by Centerline Biomedical, Inc., integrated with the company's FDA-cleared Intra-Operative Positioning System (IOPS),~2. FDA-cleared compatible sensorized guidewires added to the Cook Zenith Flex delivery system, and~3. 3D visualization on the IOPS mobile cart monitor and 3D holographic visualization overlaid on the patient during the procedure using a head mounted display (HMD), the Microsoft HoloLens 2."

Trial Locations (1)

44195

Cleveland Clinic, Cleveland

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

The Cleveland Clinic

OTHER