Abdominal Aortic Aneurysm3D-GN&CNCT06008613
3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair
A study of Abdominal Aortic Aneurysm, run by The Cleveland Clinic at 1 site in United States.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2023to 19 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient meets the instructions for use (IFU) for the 24-28 mm body Cook Zenith Flex AAA bifurcated stent graft.
- Adequate iliac/femoral access compatible with the required introduction system
- Non aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm:
- 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).
- Male/female, aged ≥ 18
- Patient fulfilling criteria for needing endovascular repair of abdominal aortic aneurysm according to routine clinical practice criteria of the participating center
Show all 9Show fewer
- 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
- Provide written informed consent as applicable and defined by site country regulation
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Contraindications for Cook Zenith Flex Aortic endograft:
- Patients with known sensitivities or allergies to stainless steel, polyester, solder (tin, silver), polypropylene, or gold
- Patients with a systemic infection who may be at increased risk of endovascular graft infection
- Presence of electronic implants, e.g., cardiac pacemaker, automatic implantable cardioverter/defibrillator (AICD) or nerve stimulator
- Presence of metallic implants above the knee, e.g., artificial hip
Show all 12Show fewer
- Patients not willing or able to give informed consent
- Pregnant women
- Patients' inability to have a contrasted CT scan
- Current or planned participation in any other investigational drug or medical device clinical study that has not completed primary endpoint(s) evaluation;
- Other medical, social, or psychological issues that in the opinion of the investigator preclude the subjects from receiving this treatment, and the procedures and evaluations pre- and posttreatment
- Anatomy outside of the IFU for a 24-28 mm Cook Zenith Flex AAA bifurcated stent graft
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D Holographic Guidance, Navigation, and Control (3D GN&C) for Endovascular Aortic Repair (EVAR)
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®.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- 3D Holographic Guidance, Navigation, and Control (3D GN&C)
- Keywords
- AAA, EVAR
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- 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),
- FDA-cleared compatible sensorized guidewires added to the Cook Zenith Flex delivery system, and
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft. Receives: Device: 3D Holographic Guidance, Navigation, and Control (3D GN&C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Implantation of Cook Zenith AAA Endovascular Graft Using the 3D-GN&C Device
Number of Patients with Correct positioning of the endovascular stent graft using the 3D-GN\&C device confirmed by fluoroscopic imaging
Measured: By the end of the procedure, average of 2 hours
Secondary outcomes (1)
Delivery System Placement in the Intended Location
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.
Measured: At the time of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start18 Oct 2023
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Francis Caputo, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008613
- Sponsor's protocol ID
- 23-753
- Other IDs
- 5R44HL139290-03
- Acronym
- 3D-GN&C
- Status last verified
- Apr 2026
- First submitted
- 9 Aug 2023
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Holographic Guidance, Navigation, and Control (3D GN&C) for Endovascular Aortic Repair (EVAR)
- ClinicalTrials.gov ID
- NCT06008613
- Acronym / sponsor ID
- 3D-GN&C / 23-753
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- AAA, EVAR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: 3D Holographic Guidance, Navigation, and Control (3D GN&C)Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient meets the instructions for use (IFU) for the 24-28 mm body Cook Zenith Flex AAA bifurcated stent graft.
- Male/female, aged ≥ 18
- Patient fulfilling criteria for needing endovascular repair of abdominal aortic aneurysm according to routine clinical practice criteria of the participating center
- 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
- Provide written informed consent as applicable and defined by site country regulation
Key exclusion criteria (12 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Contraindications for Cook Zenith Flex Aortic endograft:
- Presence of electronic implants, e.g., cardiac pacemaker, automatic implantable cardioverter/defibrillator (AICD) or nerve stimulator
- Presence of metallic implants above the knee, e.g., artificial hip
- Patients not willing or able to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention |
Primary outcome
Number of Participants With Successful Implantation of Cook Zenith AAA Endovascular Graft Using the 3D-GN&C Device
Time frame: 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
1 secondary outcome
Delivery System Placement in the Intended Location
Time frame: At the time of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Abdominal Aortic Aneurysm
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Caputo, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Abdominal Aortic Aneurysm, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Implantation of Cook Zenith AAA Endovascular Graft Using the 3D-GN&C Device (time frame: By the end of the procedure, average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.