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 range18 Years
SexALL
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:
✕. 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
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