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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 30 days

Awards & highlights

3D-GN&C Trial Summary

This trial tests a 3D imaging system to help surgeons safely operate on aneurysms in the aorta.

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.Check my eligibility

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.See study design

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.

3D-GN&C Trial Eligibility Criteria

Inclusion Criteria

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

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

3D-GN&C Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Delivery system placement in the intended location

Other outcome measures

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

3D-GN&C 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,365,555 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,852,121 Total Patients Enrolled

Francis Caputo, MDPrincipal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this trial still available?

"Per information found on clinicaltrials.gov, this trial is not taking in new volunteers at this juncture. The study was first posted on October 1st 2023 and the most recent update was August 28th of that same year. Although recruitment for this specific medical research has concluded, there are 170 other studies looking for participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008613.

All > Abdominal Aortic Aneurysm