Clinical trial NCT06008613: 3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair
Official title: 3D Holographic Guidance, Navigation, and Control (3D GN&C) for Endovascular Aortic Repair (EVAR)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: AAA
EVAR
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-08-23
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 criteria: 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;
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

Primary outcomes:
measure: Successful implantation of Cook Zenith AAA Endovascular Graft using the 3D-GN&C device
timeFrame: During the procedure
Secondary outcomes:
measure: Delivery system placement in the intended location
timeFrame: During the procedure
Other outcomes:
measure: Incidence of AE/SAE related to 3D-GN&C device
timeFrame: Through study completion, an average of 30 days
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Francis Caputo, MD
role: PRINCIPAL_INVESTIGATOR
References: