Ellipsys Vascular Access System Post Market Surveillance (PS) Study

NCT04484220 | Completed Results FDA Device

• 1 other identifier: PS200001
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Renal Disease, End Stage; Kidney Disease, End-Stage; AV Fistula; Fistulas Arteriovenous

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Primary Patency Through 12 Months Post-AVF Creation

  12 months post-procedure

• Assisted Primary Patency Through 12 Months Post-AVF Creation

  12 months post-procedure

• Secondary Procedures Rate, Per Person Years

  12 months post-procedure

• Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events

  12 months post-procedure

• Secondary Procedures Rate, Percentage of Subjects

  12 months post-procedure

Study Arms (1)

Ellipsys Vascular Access System

EXPERIMENTAL

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

Interventions

Ellipsys Vascular Access System DEVICE

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.

Ellipsys Vascular Access System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female ≥ 18 years of age and ≤ 80 years of age
• Life expectancy of at least one year, in the investigator's opinion
• Diagnosed with ESRD or chronic kidney disease on hemodialysis.
• Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment
• Adequate quality vein based on pre-operative assessment
• Adjacent vein diameter of ≥2.0 mm at target anastomosis site
• Confirmed clinically significant outflow
• Adequate quality radial artery based on pre-operative assessment
• a. Arterial lumen diameter of ≥2.0 mm at target anastomosis site
• Adequate collateral arterial perfusion with patent palmar arch as demonstrated by Barbeau Test or Allen's Test.
• Radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
• Patient is able to provide written informed consent and attend follow-up examinations at the enrolling institution
• 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
• Confirm radial artery and adjacent vein diameter of ≥2.0 mm at target anastomosis site

You may not qualify if:

• Pre-existing ipsilateral vascular disease interfering with the study procedure or potentially confounding the study results including:
• Documented or suspected central venous stenosis (≥ 50%) or
• Upper extremity arterial stenosis or
• Vascular disease at the radial artery / adjacent vein site
• 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
• History of steal syndrome from a previous surgical ipsilateral hemodialysis vascular access which required intervention or abandonment
• Systolic pressures \< 100 mg Hg at the time of screening
• Suspected or confirmed skin disease at the skin entry site
• Edema of the upper extremity on the ipsilateral side
• Immunocompromised subjects due to underlying disease or immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of \> 10 mg per day
• Known bleeding diathesis, coagulation disorder or medications putting the subject at increased risk, in the Investigator's judgment
• Patients with acute or active infection
• Scheduled kidney transplant within 6 months of enrollment
• Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form)
• History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (12)

Nephrology Associates Access Center

Riverside, California, 92501, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Azura Vascular Care, Jacksonville

Jacksonville, Florida, 32218, United States

Location

Coastal Vascular and Interventional, PLLC

Pensacola, Florida, 32504, United States

Location

Rush University Medical Center

Chicago, Illinois, 60607, United States

Location

The Vascular Care Group

Hyannis, Massachusetts, 022601, United States

Location

Nephrology Kidney Disease Hypertension Center

Las Vegas, Nevada, 89128, United States

Location

Staten Island Hospital

Staten Island, New York, 10305, United States

Location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

STAR Vascular Access Center

San Antonio, Texas, 78207, United States

Location

San Antonio Kidney Disease Center

San Antonio, Texas, 78216, United States

Location

Richmond Vascular Center

North Chesterfield, Virginia, 23236, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Limitations and Caveats

Strengths: Study events were adjudicated by an external clinical events committee (CEC) and duplex ultrasound images were evaluated by an external Core lab; study collected data on real-world use of the device. Weaknesses: This was a non-randomized, non-blinded clinical trial with inherent biases. The study demographics over-represent White subjects compared to the End-Stage Kidney Disease population.

Results Point of Contact

• Title: Heather Catchpole, Clinical Study Manager
• Organization: Medtronic Vascular, Inc.

heather.j.catchpole@medtronic.com

707-560-3395

Study Officials

• Haimanot Wasse, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 23, 2020
• Study Start: April 13, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 7, 2026
• Results First Posted: May 7, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)