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Vascular Access System
Ellipsys Vascular Access System for Arteriovenous Fistula
N/A
Waitlist Available
Led By Haimanot Wasse, MD
Research Sponsored by Medtronic Endovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Arterial lumen diameter of ≥2.0 mm at target anastomosis site
Male or non-pregnant female ≥ 18 years of age and ≤ 80 years of age
Must not have
Patients with acute or active infection
Prior vascular surgery at or proximal (central) to the AVF target site interfering with AVF maturation or other ipsilateral surgery that could potentially confound the study results such as prior axillary dissection or mastectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-procedure
Awards & highlights
Summary
This trial will look at how well the Ellipsys Vascular Access System works in people who need an AV fistula.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here as it's observational post-market surveillance focusing on the performance of the Ellipsys Vascular Access System after approval; generally such procedures may cause discomfort at the access site, possible infection risk or issues related to vascular access.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
The artery at my surgery site is at least 2.0 mm wide.
Select...
I am between 18 and 80 years old and not pregnant.
Select...
My radial artery and nearby vein are at least 2.0 mm wide where they connect.
Select...
I have been diagnosed with end-stage renal disease or am on hemodialysis for chronic kidney disease.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I currently have an active infection.
Select...
I've had surgery near the planned site for my arteriovenous fistula that could affect its development.
Select...
I am immunocompromised due to a condition or medication like sirolimus or high-dose Prednisone.
Select...
I am scheduled for a kidney transplant within the next 6 months.
Select...
I have swelling in the arm on the same side as my cancer.
Select...
I am currently hospitalized or experiencing ongoing effects from COVID-19.
Select...
I had complications from a previous dialysis access surgery that needed fixing or was abandoned.
Select...
I have a skin condition at the site where medical procedures are performed.
Select...
I do not have major blood vessel problems in the same side of my body as the study treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cumulative Patency Through 12 months Post-AVF Creation
Early Occlusion Rate at 7 days
Study Related Serious Adverse Event (SAE) Rate Through 12 months
Secondary study objectives
Assisted Primary Patency Through 12 months Post-AVF Creation
Overall Patient Safety
Primary Patency Through 12 months Post-AVF Creation
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Ellipsys Vascular Access SystemExperimental Treatment1 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.
Find a Location
Who is running the clinical trial?
Medtronic EndovascularLead Sponsor
68 Previous Clinical Trials
14,721 Total Patients Enrolled
2 Trials studying Arteriovenous Fistula
433 Patients Enrolled for Arteriovenous Fistula
Haimanot Wasse, MDPrincipal InvestigatorRush University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have an active infection.Your vein is very close to your radial artery, as shown by an ultrasound test before the procedure.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.I am scheduled for a kidney transplant within the next 6 months.The vein near the site of connection is at least 2.0 millimeters in diameter.I have swelling in the arm on the same side as my cancer.You have a confirmed significant blockage in the flow of something in your body.The artery at my surgery site is at least 2.0 mm wide.I have a bleeding or clotting disorder, or take medication that increases my bleeding risk.I am currently hospitalized or experiencing ongoing effects from COVID-19.I am between 18 and 80 years old and not pregnant.I had complications from a previous dialysis access surgery that needed fixing or was abandoned.I have a skin condition at the site where medical procedures are performed.Your blood pressure is lower than 100 mm Hg when measured.The doctor thinks you will live for at least one more year.I am considered fit for a specific type of dialysis access surgery in my arm, as per my doctor's judgment.My veins are considered good quality for surgery.My radial artery is in good condition according to a recent check.I do not have major blood vessel problems in the same side of my body as the study treatment.My radial artery and nearby vein are at least 2.0 mm wide where they connect.I have been diagnosed with end-stage renal disease or am on hemodialysis for chronic kidney disease.You have good blood flow in the arteries of your hand, shown by specific tests.The distance between the radial artery and a nearby vein is less than 1.5 millimeters, as measured by ultrasound before the procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Ellipsys Vascular Access System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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