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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44HL139290-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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®.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | By the end of the procedure, average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the time of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) Related to 3D-GN&C Device | Incidence of SAE (serious adverse events) related to 3D-GNC device as well as incidence of non-SAE (non-Serious Adverse Events) related to 3D-GNC device | Through study completion, an average of 30 days |
Inclusion Criteria:
The patient meets the instructions for use (IFU) for the 24-28 mm body Cook Zenith Flex AAA bifurcated stent graft.
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).
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:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Francis Caputo, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft. 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 endovascuar aneurysm repair (EVAR). EM guidance and tracking is enabled using a system consisting of:
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft. 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | By the end of the procedure, average of 2 hours |
|
Up tp 30 daus
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft. 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:
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francis Caputo, MD | Cleveland Clinic | 216-445-9580 | CAPUTOF@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2023 | Feb 24, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 5, 2024 | Feb 24, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Size of Infrarenal Aneurysm | Mean | Full Range | cm |
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| Secondary | 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. | Posted | Count of Participants | Participants | At the time of the procedure |
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| Other Pre-specified | Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) Related to 3D-GN&C Device | Incidence of SAE (serious adverse events) related to 3D-GNC device as well as incidence of non-SAE (non-Serious Adverse Events) related to 3D-GNC device | Posted | Count of Participants | Participants | Through study completion, an average of 30 days |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D001018 |
| Aortic Diseases |