Trial Outcomes & Findings for 3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair (NCT NCT06008613)

Last Updated: 2026-04-24

Results Overview

Number of Patients with Correct positioning of the endovascular stent graft using the 3D-GN\&C device confirmed by fluoroscopic imaging

Recruitment status

COMPLETED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

By the end of the procedure, average of 2 hours

Results posted on

2026-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft. 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 endovascuar aneurysm repair (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.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=2 Participants Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft. 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.
Age, Categorical <=18 years	0 Participants n=2 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=2 Participants
Age, Categorical >=65 years	2 Participants n=2 Participants
Sex: Female, Male Female	0 Participants n=2 Participants
Sex: Female, Male Male	2 Participants n=2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=2 Participants
Race (NIH/OMB) Asian	0 Participants n=2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=2 Participants
Race (NIH/OMB) Black or African American	0 Participants n=2 Participants
Race (NIH/OMB) White	1 Participants n=2 Participants
Race (NIH/OMB) More than one race	0 Participants n=2 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=2 Participants
Size of Infrarenal Aneurysm	5.4 cm n=2 Participants

PRIMARY outcome

Timeframe: By the end of the procedure, average of 2 hours

Number of Patients with Correct positioning of the endovascular stent graft using the 3D-GN\&C device confirmed by fluoroscopic imaging

Outcome measures

Outcome measures
Measure	Intervention n=2 Participants Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft. 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.
Number of Participants With Successful Implantation of Cook Zenith AAA Endovascular Graft Using the 3D-GN&C Device	2 Participants

SECONDARY outcome

Timeframe: At the time of the procedure

Number of patients with the delivery system located in the intended location confirmed by measuring the distance between the fluoroscopy and digital subtraction angiography less than 6 mms.

Outcome measures

Outcome measures
Measure	Intervention n=2 Participants Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft. 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.
Delivery System Placement in the Intended Location	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 30 days

Incidence of SAE (serious adverse events) related to 3D-GNC device as well as incidence of non-SAE (non-Serious Adverse Events) related to 3D-GNC device

Outcome measures

Outcome measures
Measure	Intervention n=2 Participants Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft. 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.
Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) Related to 3D-GN&C Device	0 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Francis Caputo, MD

Cleveland Clinic

Phone: 216-445-9580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place