Ellipsys Vascular Access System Post Market Surveillance (PS) Study

Ellipsys Vascular Access System Post Market Surveillance (PS) Study PS200001 Reference DEN170004

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.

Study Overview

• Status: Completed
• Conditions: AV Fistula; Fistulas Arteriovenous; Renal Disease, End Stage; Kidney Disease, End-Stage
• Intervention / Treatment: Device: Ellipsys Vascular Access System

Detailed Description

The primary objective of this post-market surveillance study is to support the short-term safety of the device and procedure and further assess long-term safety and effectiveness in subjects treated by newly trained providers of the Ellipsys Vascular Access System in the creation of a native AV fistula via percutaneous access in subjects who are on hemodialysis and are medically indicated for the creation of an upper limb anastomosis.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Riverside, California, United States, 92501
      • Nephrology Associates Access Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • Florida
    • Jacksonville, Florida, United States, 32218
      • Azura Vascular Care, Jacksonville
    • Pensacola, Florida, United States, 32504
      • Coastal Vascular and Interventional, PLLC
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Rush University Medical Center
  • Massachusetts
    • Hyannis, Massachusetts, United States, 022601
      • The Vascular Care Group
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Nephrology Kidney Disease Hypertension Center
  • New York
    • Staten Island, New York, United States, 10305
      • Staten Island Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburg Medical Center
  • Texas
    • San Antonio, Texas, United States, 78207
      • STAR Vascular Access Center
    • San Antonio, Texas, United States, 78216
      • San Antonio Kidney Disease Center
  • Virginia
    • North Chesterfield, Virginia, United States, 23236
      • Richmond Vascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or non-pregnant female ≥ 18 years of age and ≤ 80 years of age
2. Life expectancy of at least one year, in the investigator's opinion
3. Diagnosed with ESRD or chronic kidney disease on hemodialysis.
4. Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment

5. Adequate quality vein based on pre-operative assessment

   1. Adjacent vein diameter of ≥2.0 mm at target anastomosis site
   2. Confirmed clinically significant outflow

6. Adequate quality radial artery based on pre-operative assessment

   a. Arterial lumen diameter of ≥2.0 mm at target anastomosis site

7. Adequate collateral arterial perfusion with patent palmar arch as demonstrated by Barbeau Test or Allen's Test.
8. Radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure

9. Patient is able to provide written informed consent and attend follow-up examinations at the enrolling institution

   Imaging-based Inclusion Criteria:

10. Confirm radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedurally
11. Confirm radial artery and adjacent vein diameter of ≥2.0 mm at target anastomosis site

Exclusion Criteria:

1. Pre-existing ipsilateral vascular disease interfering with the study procedure or potentially confounding the study results including:

   1. Documented or suspected central venous stenosis (≥ 50%) or
   2. Upper extremity arterial stenosis or
   3. Vascular disease at the radial artery / adjacent vein site
2. 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
3. History of steal syndrome from a previous surgical ipsilateral hemodialysis vascular access which required intervention or abandonment
4. Systolic pressures < 100 mg Hg at the time of screening
5. Suspected or confirmed skin disease at the skin entry site
6. Edema of the upper extremity on the ipsilateral side
7. Immunocompromised subjects due to underlying disease or immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of > 10 mg per day
8. Known bleeding diathesis, coagulation disorder or medications putting the subject at increased risk, in the Investigator's judgment
9. Patients with acute or active infection
10. Scheduled kidney transplant within 6 months of enrollment
11. Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form)
12. History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment
13. Patient has an active COVID-19 infection with ongoing sequela or hospitalization for treatment of COVID-19.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ellipsys Vascular Access System; 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.	Device: Ellipsys Vascular Access System; 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 with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Patency Through 12 Months Post-AVF Creation	Freedom from access abandonment from time of access creation	12 months post-procedure
Early Occlusion Rate at 7 Days	Percent of patients with total occlusion within 7 days of the AVF creation procedure	7 days post-procedure
Study Related Serious Adverse Event (SAE) Rate Through 12 Months	This event rate is reported as the percentage of participants with at least one Serious Adverse Event through 12 Months, related to the device, study procedure, or secondary procedure to maintain or re-establish patency.	12 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency Through 12 Months Post-AVF Creation	Freedom from access thrombosis or any intervention designed to facilitate, maintain or re-establish patency measured from time of access creation through 12 months	12 months post-procedure
Assisted Primary Patency Through 12 Months Post-AVF Creation	Freedom from access thrombosis from time of access creation through 12 months post-AVF creation	12 months post-procedure
Secondary Procedures Rate, Per Person Years	Secondary procedure rate will be summarized cumulatively through 12 months as the number of procedures per person-years as well as the number and percentage of subjects having one or more procedures in the Treated population (see 8. Secondary Outcome Measure).	12 months post-procedure
Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events	A full characterization of adverse events during the study	12 months post-procedure
Secondary Procedures Rate, Percentage of Subjects	Secondary procedure rate will be summarized cumulatively through 12 months as the number of procedures per person-years as well as the number and percentage of subjects having one or more procedures in the Treated population. (see 6. Secondary Outcome Measure)	12 months post-procedure

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: Haimanot Wasse, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Congenital Abnormalities; Cardiovascular Abnormalities; Renal Insufficiency, Chronic; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Arteriovenous Fistula
• Other Study ID Numbers: PS200001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes