What side effects are associated with this type of intervention?

Endovascular Aneurysm Repair (EVAR) for Abdominal Aortic Aneurysm (AAA) is generally associated with fewer complications compared to open surgical repair. Common side effects include groin pain, bleeding, and infection at the catheter insertion site. There is also a risk of endoleaks, where blood continues to flow into the aneurysm sac, potentially requiring further intervention. Other potential complications include damage to surrounding blood vessels, kidney damage due to contrast dye used in imaging, and, rarely, spinal cord injury. The use of advanced guidance systems like 3D holographic navigation aims to reduce these risks by improving precision during the procedure.

What prior FDA approvals exist?

The FDA has approved several endovascular graft systems for the treatment of Abdominal Aortic Aneurysm (AAA), including the Cook Zenith Flex AAA Endovascular Graft, which is being studied in the 3D Holographic Guidance, Navigation, and Control trial. These graft systems are designed to reinforce the weakened area of the aorta and prevent rupture. Other similar devices include the Medtronic Endurant II and the Gore Excluder AAA Endoprosthesis. These treatments involve minimally invasive endovascular procedures, which are less invasive than open surgery and have been shown to be effective in managing AAA.

What other types of research exist?

Promising novel alternatives to 3D Holographic Guidance, Navigation, and Control for AAA treatment include: 1) Advanced robotic-assisted endovascular systems, which offer enhanced precision and control during procedures. 2) Augmented reality (AR) systems that overlay critical imaging data onto the surgical field in real-time. 3) Artificial intelligence (AI)-driven imaging and navigation platforms that provide real-time analytics and decision support. 4) Next-generation fluoroscopic imaging with reduced radiation exposure and improved image clarity. These technologies aim to improve procedural accuracy, reduce complications, and enhance patient outcomes.

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3D Holographic Surgery Assistance for Aortic Aneurysm (3D-GN&C Trial)

N/A

Recruiting

Led By Francis Caputo, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Be older than 18 years old

Must not have

Patients' inability to have a contrasted CT scan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the procedure

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications related to incorrect graft placement due to guidance system errors, reactions from contrast media used in imaging, or issues arising from standard risks associated with endovascular surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My aorta and iliac arteries fit the required sizes and angles for the procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot have a CT scan with contrast.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Successful implantation of Cook Zenith AAA Endovascular Graft using the 3D-GN&C device

Secondary study objectives

Delivery system placement in the intended location

Other study objectives

Incidence of AE/SAE related to 3D-GN&C device

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Endovascular aneurysm repair (EVAR) is a common treatment for Abdominal Aortic Aneurysm (AAA) that involves inserting a stent-graft through the femoral artery to the aneurysm site. The stent-graft expands and attaches to the aortic wall, creating a new path for blood flow and reducing pressure on the aneurysm. This minimally invasive approach is significant for AAA patients as it generally results in shorter recovery times, reduced operative risks, and fewer complications compared to open surgery. Enhanced visual guidance, such as 3D holographic technology, can improve the precision and safety of EVAR by providing real-time, detailed anatomical views, potentially leading to better outcomes.

Holographically-Guided Endovascular Aneurysm Repair.Systematic Review of Off-the-Shelf or Physician-Modified Fenestrated and Branched Endografts.