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Holographic navigation could make aortic surgery safer
NCT ID NCT06008613
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early feasibility study tested a 3D holographic guidance system to help surgeons place stent grafts during endovascular aortic repair (EVAR) for abdominal aortic aneurysms. Two patients participated, and the system was used alongside standard X-ray imaging to confirm correct placement. The goal was to see if the holographic guidance could improve precision and reduce reliance on radiation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 3D holographic guidance, navigation, and control (3D-GN&C) device
- What this could lead to
- If successful, this technology could make aortic aneurysm repair more precise and reduce the need for X-ray imaging during surgery.
- What could go wrong
- This was a very small early study with only 2 participants, so results may not apply to all patients. The device is experimental and requires further testing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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2 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, automatic implantable cardioverter/defibrillator (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; 8. 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 9. Anatomy outside of the IFU for a 24-28 mm Cook Zenith Flex AAA bifurcated stent graft
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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