3D Holographic Surgery Assistance for Aortic Aneurysm

(3D-GN&C Trial)

Overseen By Francis Caputo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Electronic implants, Metallic implants, Systemic infection, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

3 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new technology that uses 3D holograms and sensors to help doctors place stents more accurately in patients undergoing a specific type of blood vessel repair. The goal is to make the procedure safer and more precise.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is 3D Holographic Surgery Assistance for Aortic Aneurysm generally safe for humans?

The safety of 3D Holographic Surgery Assistance for Aortic Aneurysm isn't directly addressed in the available research, but related procedures like endovascular surgery for aortic aneurysms have been studied. Common complications in similar procedures include thromboembolic events (blood clots), groin-site hematoma (bruising), and contrast-induced nephropathy (kidney issues), with various strategies in place to reduce these risks. ^{1 2 3 4 5}

How does 3D Holographic Surgery Assistance for Aortic Aneurysm differ from other treatments?

3D Holographic Surgery Assistance for Aortic Aneurysm is unique because it uses advanced imaging techniques to create a three-dimensional model of the aorta, which helps surgeons visualize and plan the surgery more accurately. This approach differs from traditional methods that rely on two-dimensional images and may improve surgical outcomes by providing a more detailed view of the aneurysm and surrounding structures. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment 3D GN&C for aortic aneurysm?

The use of 3D visualization techniques, such as virtual reality and holograms, has been shown to improve surgeons' understanding of complex aortic anatomy and aid in preoperative planning, which could enhance the effectiveness of treatments like 3D GN&C for aortic aneurysms. ^{7 8 11 12 13}

Who Is on the Research Team?

Francis Caputo, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

Adults who need endovascular repair for abdominal aortic aneurysm and fit the specific size criteria for the Cook Zenith Flex AAA stent graft can join. Women must not be pregnant or planning pregnancy. Participants should agree to all study procedures, have no allergies to stent materials, no systemic infections, and no electronic or metallic implants above the knee.

Inclusion Criteria

I need a procedure for my abdominal aortic aneurysm as per my doctor's advice.

My veins are suitable for the necessary medical procedure.

I am not pregnant, breastfeeding, or planning to become pregnant, and I had a negative pregnancy test recently.

Exclusion Criteria

The anatomy does not fit the instructions for use for a specific stent graft.

I cannot have a CT scan with contrast.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Electromagnetic guidance and tracking used to place Cook Zenith Flex AAA bifurcated stent graft

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3D GN&C

Trial Overview The trial is testing a new technology called 3D GN&C as an add-on tool during surgery with Cook Zenith Flex AAA Endovascular Graft. It aims to improve navigation and placement of the graft in patients with abdominal aortic aneurysms.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Thromboembolic events are the most common adverse occurrences in endovascular neurosurgery, with incidence rates varying from 2% to 61%, highlighting the need for effective prevention strategies, although optimal use of anticoagulants remains unclear.

Groin-site hematomas are the most frequent access-related complications, with an incidence of 9% to 32%, and there is a lack of standardized protocols for prevention, indicating a need for systematic guidelines to improve safety in neurosurgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns in neurosurgical adverse events: endovascular neurosurgery. Wong, JM., Ziewacz, JE., Panchmatia, JR., et al.[2012]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Detailed Measurement of Wall Strain with 3D Speckle Tracking in the Aortic Root: A Case of Bionic Support for Clinical Decision Making. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality Angiogram vs 3-Dimensional Printed Angiogram as an Educational tool-A Comparative Study. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality in the Preoperative Planning of Adult Aortic Surgery: A Feasibility Study. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Vascular Deformation Mapping (VDM) of Thoracic Aortic Enlargement in Aneurysmal Disease and Dissection. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Cinematic Rendering in Mixed-Reality Holograms: A New 3D Preoperative Planning Tool in Pediatric Heart Surgery. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Elective ascending aortic aneurysm repair outcomes in a nationwide US cohort. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

German registry for acute aortic dissection type A (GERAADA)--lessons learned from the registry. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Patterns in neurosurgical adverse events: endovascular neurosurgery. [2012]

9. England pubmed.ncbi.nlm.nih.gov

The influence of team experience on outcomes of endovascular stenting of abdominal aortic aneurysms. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Treatment of aortic aneurysms registered in Swedvasc: Development reflected in a national vascular registry with an almost 100% coverage. [2020]

11. Japan pubmed.ncbi.nlm.nih.gov

[Preoperative diagnosis of the thoracic aortic aneurysm by three-dimensional CT angiography]. [2016]

12. England pubmed.ncbi.nlm.nih.gov

A novel vision-based system for quantitative analysis of abdominal aortic aneurysm deformation. [2020]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Image-Based 3D Characterization of Abdominal Aortic Aneurysm Deformation After Endovascular Aneurysm Repair. [2020]