3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair (NCT06008613) | Clinical Trial Compass
CompletedNot Applicable
3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair
United States2 participantsStarted 2023-10-18
Plain-language 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®.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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
. Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria
. Contraindications for Cook Zenith Flex Aortic endograft:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Successful Implantation of Cook Zenith AAA Endovascular Graft Using the 3D-GN&C Device
Timeframe: By the end of the procedure, average of 2 hours