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

3D Holographic Guidance, Navigation, and Control (3D GN&C) for Endovascular Aortic Repair (EVAR)

NCT06008613•The Cleveland Clinic

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.

Detailed Description

The goal of this clinical study is to evaluate the feasibility of 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 the following: 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. Planning and execution of each case will be major steps in demonstrating feasibility of the technology beyond non-clinical and preclinical testing.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient meets the instructions for use (IFU) for the 24-28 mm body Cook Zenith Flex AAA bifurcated stent graft.
•1. Adequate iliac/femoral access compatible with the required introduction system
•2. Non aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm:
•i. With a length of at least 15mm ii. With a diameter measured outer wall to outer wall of no greater than 26mm and no less than 20mm iii. With an angle less than 60 degrees relative to the long access of the aneurysm and iv. With an angle less than 45 degrees relative to the axis of the suprarenal aorta c. Iliac artery distal fixation site greater than 10mm in length and 7.5-20mm in diameter (measured outerwall to outerwall).
•2. Male/female, aged ≥ 18
•3. Patient fulfilling criteria for needing endovascular repair of abdominal aortic aneurysm according to routine clinical practice criteria of the participating center
•4. Women of childbearing potential must be non-pregnant, non-lactating, and not planning to become pregnant during the course of the trial; and have a negative urine or serum pregnancy test within 7 days prior to index procedure
•5. Provide written informed consent as applicable and defined by site country regulation
•6. Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

•An individual who meets any of the following criteria will be excluded from participation in this study:
•1. Contraindications for Cook Zenith Flex Aortic endograft:
•1. Patients with known sensitivities or allergies to stainless steel, polyester, solder (tin, silver), polypropylene, or gold
•2. Patients with a systemic infection who may be at increased risk of endovascular graft infection
•2. Presence of electronic implants, e.g., cardiac pacemaker, AICD or nerve stimulator
•3. Presence of metallic implants above the knee, e.g., artificial hip
•4. Patients not willing or able to give informed consent
•5. Pregnant women
•6. Patients' inability to have a contrasted CT scan
•7. Current or planned participation in any other investigational drug or medical device clinical study that has not completed primary endpoint(s) evaluation;
+2 more criteria

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Key Dates

Start Date

October 18, 2023

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

April 18, 2025

Enrollment

ESTIMATED participants

Conditions

Abdominal Aortic Aneurysm

Interventions

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

DEVICE

PET Imaging of MMP Activation in AAA: Clinical Component

NCT07473102

Abdominal Aortic Aneurysm

View study

RECRUITING

Terumo Aortic Global Endovascular Registry

NCT04246463

Abdominal Aortic AneurysmThoracic Aortic Aneurysm+1 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

PET Imaging of MMP Activation in AAA: Clinical Component

Terumo Aortic Global Endovascular Registry

Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft

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Investigating Practice Patterns in Symptomatic Non-ruptured Abdominal Aortic Aneurysms (AAA) in Europe