Ellipsys Vascular Access System for Arteriovenous Fistula

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the Ellipsys Vascular Access System for individuals with chronic kidney disease who require an arteriovenous fistula for dialysis. The goal is to determine if this system can safely and effectively create the necessary connection for dialysis treatment. Suitable candidates have chronic kidney disease, are already on dialysis, and possess veins and arteries that meet specific size criteria. As an unphased trial, this study allows patients to contribute to innovative research that could enhance dialysis treatment options.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressant therapy like sirolimus or Prednisone over 10 mg per day, you may not be eligible to participate.

What prior data suggests that the Ellipsys Vascular Access System is safe for creating arteriovenous fistulas?

Research has shown that the Ellipsys Vascular Access System is generally safe for creating an arteriovenous fistula, a connection between an artery and a vein. One study found that this system offers a reliable and safe method for making this connection. The procedure is minimally invasive, involving less cutting and a shorter recovery time.

The system has been tested in the U.S. for over five years, demonstrating strong results in both safety and effectiveness. Notably, it has a high success rate in helping the fistula develop properly, which is crucial for patients requiring regular dialysis. The clinical study provides reasonable assurance that the Ellipsys System is safe and effective for patients with chronic kidney disease who need this type of access for treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Ellipsys Vascular Access System is unique because it offers a minimally invasive way to create an arteriovenous fistula for dialysis patients. Unlike the standard surgical approach, which requires a more extensive operation, the Ellipsys System uses a specialized device to connect a proximal radial artery to a perforating vein through a small puncture in the skin. This innovative approach can reduce recovery time and lower the risk of complications, which are common with traditional surgical methods. Researchers are excited about this system's potential to improve patient comfort and streamline the process of preparing for dialysis.

What evidence suggests that the Ellipsys Vascular Access System is effective for creating arteriovenous fistulas?

Research has shown that the Ellipsys Vascular Access System effectively creates connections between an artery and a vein, known as arteriovenous fistulas, for patients needing dialysis. One study provided strong evidence of its safety and effectiveness in forming these connections. However, another study found that fistulas created with Ellipsys sometimes took longer to develop properly for dialysis use. Despite this, the system has been used successfully and offers a less invasive option compared to traditional surgery. Potential participants should consider both the benefits and the initial challenges observed. ^{2 4 6 7 8}

Who Is on the Research Team?

Haimanot Wasse, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

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 scheduled for a kidney transplant within the next 6 months.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9931805/

Technical aspects of percutaneous endovascular ... This report summarizes the essential elements for AVF creation with the Ellipsys® Vascular Access System and investigates feasibility, efficacy, and safety ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890509621001011

Initial Outcomes Following Introduction of Percutaneous ... Patients undergoing Ellipsys-created pAVF in the first year following introduction of percutaneous endovascular had inferior rates of clinical maturation.

3. jvascsurg.org jvascsurg.org/article/S0741-5214(23)02208-5/fulltext

Cost-effectiveness analysis of endovascular vs surgical ... EndoAVF is not cost effective compared with sAVF when modeling 5-year outcomes. The main driver of sAVF remaining cost effective is the four times higher up- ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN170004.pdf

den170004 summary - accessdata.fda.gov Conclusions: The clinical study demonstrated that there is a reasonable assurance of safety and effectiveness that the Ellipsys System creates an arteriovenous ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06679907

Study Details | NCT06679907 | Medico-economic ... This multicenter 1 :1 randomized controlled trial aims at comparing the cost-effectiveness of endovascular arteriovenous fistula (AVF) creation using ...

6. medtronic.com medtronic.com/en-us/l/isw/ellipsys-vascular-access-system-indications-safety-warnings.html

Indications, Safety, and Warnings - Ellipsys Vascular ... The Ellipsys system is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach.

7. europe.medtronic.com europe.medtronic.com/xd-en/healthcare-professionals/products/cardiovascular/arteriovenous-fistula-creation/ellipsys-vascular-access-system.html

Ellipsys Vascular Access System - Arteriovenous Fistula ... The EllipsysTM System is the only one of its kind with five-year U.S. clinical trial data1,3 demonstrating three critical metrics: 88% maturation rate at 90 ...

8. southcarolinablues.com southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/percutaneous-arteriovenous-fistula/

Percutaneous Arteriovenous Fistula - CAM 383HB The authors concluded the Ellipsys AVF Vascular Access System allows for rapid and safe creation of a reliable autogenous access, with rates of technical ...