CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2 enrolled
Drug / intervention
3D Holographic Guidance, Navigation, and Control (3D GN&C)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06008613
NCT06008613N/ACompleted
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3D Holographic Guidance, Navigation, and Control (3D GN&C) for Endovascular Aortic Repair (EVAR)

The Cleveland Clinic·interventional·Posted Aug 23, 2023·Updated Apr 24, 2026

In Brief

A clinical study evaluating 3D Holographic Guidance, Navigation, and Control (3D GN&C) for Abdominal Aortic Aneurysm. Completed, enrolled 2 participants across 1 site.

Detailed Summary

This is an Early Feasibility Study to evaluate the usability, safety and functionality of 3D holographic guidance, navigation, and control (3D-GNC) as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft®.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbdominal Aortic Aneurysm
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
202420252026
First PostedAug 23, 2023
Enrollment StartOct 18, 2023
Primary CompletionJun 19, 2025
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 2.9 years ago

Interventions

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

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.