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3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair (3D-GN&C)

Primary Purpose

Abdominal Aortic Aneurysm

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D Holographic Guidance, Navigation, and Control (3D GN&C)
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Abdominal Aortic Aneurysm focused on measuring AAA, EVAR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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: 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 Presence of electronic implants, e.g., cardiac pacemaker, 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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft.

Outcomes

Primary Outcome Measures

Successful implantation of Cook Zenith AAA Endovascular Graft using the 3D-GN&C device
Correct positioning of the endovascular stent graft confirmed by fluoroscopic imaging

Secondary Outcome Measures

Delivery system placement in the intended location
Distance between the fluoroscopy and digital subtraction angiography (mm)

Full Information

First Posted
August 9, 2023
Last Updated
August 28, 2023
Sponsor
The Cleveland Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT06008613
Brief Title
3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair
Acronym
3D-GN&C
Official Title
3D Holographic Guidance, Navigation, and Control (3D GN&C) for Endovascular Aortic Repair (EVAR)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
AAA, EVAR

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft.
Intervention Type
Device
Intervention Name(s)
3D Holographic Guidance, Navigation, and Control (3D GN&C)
Intervention Description
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: 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), FDA-cleared compatible sensorized guidewires added to the Cook Zenith Flex delivery system, and 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.
Primary Outcome Measure Information:
Title
Successful implantation of Cook Zenith AAA Endovascular Graft using the 3D-GN&C device
Description
Correct positioning of the endovascular stent graft confirmed by fluoroscopic imaging
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Delivery system placement in the intended location
Description
Distance between the fluoroscopy and digital subtraction angiography (mm)
Time Frame
During the procedure
Other Pre-specified Outcome Measures:
Title
Incidence of AE/SAE related to 3D-GN&C device
Description
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
Time Frame
Through study completion, an average of 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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: 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 Presence of electronic implants, e.g., cardiac pacemaker, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francis Caputo, MD
Phone
216-445-9580
Email
caputof@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis Caputo, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Caputo, MD
Phone
216-445-9580
Email
caputof@ccf.org
First Name & Middle Initial & Last Name & Degree
Yuki Kuramochi, BSN, RN
Phone
216-445-4063
Email
kuramoy@ccf.org

12. IPD Sharing Statement

Plan to Share IPD
No

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3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair

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