Ellipsys Vascular Access System for Arteriovenous Fistula

Recruiting at 11 trial locations

Overseen By Heather Catchpole

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Endovascular

Must not be taking: Immunosuppressants, others

Disqualifiers: Vascular disease, Immunocompromised, Infection, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

142 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.

Research Team

Haimanot Wasse, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

This trial is for adults aged 18-80 with chronic kidney disease or on hemodialysis needing an arteriovenous (AV) fistula. Candidates must have certain vein and artery sizes, be medically eligible for AV fistula creation, and able to attend follow-ups. Exclusions include upper extremity edema, bleeding disorders, active infections including COVID-19, scheduled kidney transplant within 6 months, substance abuse history, low blood pressure at screening time.

Inclusion Criteria

Your vein is very close to your radial artery, as shown by an ultrasound test before the procedure.

The vein near the site of connection is at least 2.0 millimeters in diameter.

You have a confirmed significant blockage in the flow of something in your body.

Exclusion Criteria

I currently have an active infection.

I've had surgery near the planned site for my arteriovenous fistula that could affect its development.

I am immunocompromised due to a condition or medication like sirolimus or high-dose Prednisone.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Creation of a native AV fistula using the Ellipsys Vascular Access System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-term follow-up

Further assessment of long-term safety and effectiveness

12 months

Treatment Details

Interventions

• Ellipsys Vascular Access System

Trial Overview The Ellipsys Vascular Access System is being observed in this study. It's a single-arm post-market surveillance of the system used to create AV fistulas in patients who need them due to kidney conditions. The study will monitor how well it works and its safety after being approved for use.

Participant Groups

Group I: Ellipsys Vascular Access System Experimental Treatment 1 Intervention

The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients who have chronic kidney disease requiring dialysis.

Who Is Running the Clinical Trial?

Medtronic Endovascular

Lead Sponsor

Trials

70

Recruited

15,000+

Geoff Martha

Medtronic Endovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Simona Zannetti

Medtronic Endovascular

Chief Medical Officer since 2024

MD from University of Perugia Medical School, research fellowship in vascular surgery at Massachusetts General Hospital, Harvard Medical School