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CompletedNCT04484220Updated Jun 1, 2026Results posted

Ellipsys Vascular Access System Post Market Surveillance (PS) Study

An interventional study of Ellipsys Vascular Access System in Renal Disease, End Stage, Kidney Disease, End-Stage and AV Fistula, sponsored by Medtronic Endovascular. Completed at 12 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Medtronic Endovascular · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Disease, End Stage
  • Kidney Disease, End-Stage
  • AV Fistula
  • Fistulas Arteriovenous
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
142 participants (actual)

Study arms

  • 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

Interventions

  • DeviceEllipsys 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.

05

What researchers measure

Primary outcomes

  1. Cumulative Patency Through 12 Months Post-AVF Creation

    Freedom from access abandonment from time of access creation

    Time frame: 12 months post-procedure

  2. Early Occlusion Rate at 7 Days

    Percent of patients with total occlusion within 7 days of the AVF creation procedure

    Time frame: 7 days post-procedure

  3. 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.

    Time frame: 12 months post-procedure

Secondary outcomes

  1. 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

    Time frame: 12 months post-procedure

  2. Assisted Primary Patency Through 12 Months Post-AVF Creation

    Freedom from access thrombosis from time of access creation through 12 months post-AVF creation

    Time frame: 12 months post-procedure

  3. 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).

    Time frame: 12 months post-procedure

  4. 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

    Time frame: 12 months post-procedure

  5. 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)

    Time frame: 12 months post-procedure

06

Results

Posted May 7, 2026
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.

Participant flow

Participant flow — Overall Study
MilestoneEllipsys Vascular Access System
Started142
Safety population131
Completed98
Not completed44
Withdrew: Adverse event3
Withdrew: Death7
Withdrew: Physician decision11
Withdrew: Withdrawal by subject5
Withdrew: Kidney transplant2
Withdrew: Peritoneal dialysis2
Withdrew: Lost to follow-up3
Withdrew: No procedure initiated, withdrawn prior to procedure6
Withdrew: Unsuccessful procedure, device not attempted to be used5

Outcome measures

PrimaryCumulative Patency Through 12 Months Post-AVF Creation

Freedom from access abandonment from time of access creation

Time frame:
12 months post-procedure
Reported as:
Number · Probability as a percentage
Cumulative Patency Through 12 Months Post-AVF Creation
Probability as a percentageEllipsys Vascular Access System
Cumulative Patency Through 12 Months Post-AVF Creation99.1 (97.4 to 100)
PrimaryEarly Occlusion Rate at 7 Days

Percent of patients with total occlusion within 7 days of the AVF creation procedure

Time frame:
7 days post-procedure
Reported as:
Number · Percentage of Subjects
Early Occlusion Rate at 7 Days
Percentage of SubjectsEllipsys Vascular Access System
Early Occlusion Rate at 7 Days1.5 (0.4 to 6.3)
PrimaryStudy 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.

Time frame:
12 months post-procedure
Reported as:
Number · percentage of participants
Study Related Serious Adverse Event (SAE) Rate Through 12 Months
percentage of participantsEllipsys Vascular Access System
Procedure related Post-market events with 97.5% CI13.7 (8.3 to 21.8)
Procedure or Device related Serious Adverse Events Post-market events with 97.5% CI12.2 (7.2 to 20.1)
UADE Post-market events with 97.5% CI0 (0 to 3.7)
SecondaryPrimary 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

Time frame:
12 months post-procedure
Reported as:
Number · Probability as a percentage
Primary Patency Through 12 Months Post-AVF Creation
Probability as a percentageEllipsys Vascular Access System
Primary Patency Through 12 Months Post-AVF Creation54.1 (45.9 to 63.9)
SecondaryAssisted Primary Patency Through 12 Months Post-AVF Creation

Freedom from access thrombosis from time of access creation through 12 months post-AVF creation

Time frame:
12 months post-procedure
Reported as:
Number · Probability as a percentage
Assisted Primary Patency Through 12 Months Post-AVF Creation
Probability as a percentageEllipsys Vascular Access System
Assisted Primary Patency Through 12 Months Post-AVF Creation90.1 (85 to 95.6)
SecondarySecondary 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).

Time frame:
12 months post-procedure
Reported as:
Number · procedures per person-years
Secondary Procedures Rate, Per Person Years
procedures per person-yearsEllipsys Vascular Access System
Secondary Procedures Rate, Per Person Years2.02
SecondaryOverall 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

Time frame:
12 months post-procedure
Reported as:
Number · percentage of subjects reporting event
Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events
percentage of subjects reporting eventEllipsys Vascular Access System
Serious Adverse Events42
Device Related Adverse Events6.1
Procedure Related Adverse Events13.7
Intra-Procedure Related Adverse Events6.1
Secondary Procedure Related Adverse Events8.4
4-week Maturation Related Adverse Events2.3
Cannulation Related Adverse Event7.6
Total Adverse Events47.3
SecondarySecondary 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)

Time frame:
12 months post-procedure
Reported as:
Count of participants · Participants
Secondary Procedures Rate, Percentage of Subjects
ParticipantsEllipsys Vascular Access System
Subjects with zero (0) secondary procedures20
Subjects with one (1) secondary procedures37
Subjects with two (2) secondary procedures42
Subjects with three (3) secondary procedures12
Subjects with four (4 +) or more secondary procedures20

Adverse events

Collected over through 12 months. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ellipsys Vascular Access System7/131 (5.3%)55/131 (42%)3/131 (2.3%)
Most frequent serious events
Showing 10 of 78
Most frequent serious events
EventEllipsys Vascular Access System
Peripheral Vein StenosisVascular disorders6/131
Arteriovenous Fistula Site ComplicationInjury, poisoning and procedural complications5/131
PneumoniaInfections and infestations4/131
Venous Thrombosis LimbVascular disorders4/131
AnaemiaBlood and lymphatic system disorders3/131
Arteriovenous Fistula OcclusionInjury, poisoning and procedural complications3/131
Arteriovenous Fistula ThrombosisInjury, poisoning and procedural complications3/131
Device Difficult To UseInjury, poisoning and procedural complications3/131
HyperkalaemiaMetabolism and nutrition disorders3/131
Steal SyndromeVascular disorders3/131
Most frequent other events
Most frequent other events
EventEllipsys Vascular Access System
Arteriovenous Fistula ThrombosisInjury, poisoning and procedural complications3/131
Vascular Access Site HaematomaInjury, poisoning and procedural complications3/131

Baseline characteristics

The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.

Age, Continuous
Age, Continuous(years)Ellipsys Vascular Access System
Mean60.1 ± 14.1
Sex: Female, Male
Sex: Female, Male(Participants)Ellipsys Vascular Access System
Female40
Male91
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Ellipsys Vascular Access System
Hispanic or Latino61
Not Hispanic or Latino67
Unknown or Not Reported3
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Ellipsys Vascular Access System
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander1
Black or African American16
White98
More than one race0
Unknown or Not Reported14
Region of Enrollment
Region of Enrollment(Participants)Ellipsys Vascular Access System
United States131
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m2)Ellipsys Vascular Access System
Mean29.3 ± 6.9
07

Study locations

12 sites
  • Nephrology Associates Access Center
    Riverside, California 92501, United States
  • Yale University
    New Haven, Connecticut 06510, United States
  • Azura Vascular Care, Jacksonville
    Jacksonville, Florida 32218, United States
  • Coastal Vascular and Interventional, PLLC
    Pensacola, Florida 32504, United States
  • Rush University Medical Center
    Chicago, Illinois 60607, United States
  • The Vascular Care Group
    Hyannis, Massachusetts 022601, United States
  • Nephrology Kidney Disease Hypertension Center
    Las Vegas, Nevada 89128, United States
  • Staten Island Hospital
    Staten Island, New York 10305, United States
  • University of Pittsburg Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • STAR Vascular Access Center
    San Antonio, Texas 78207, United States
  • San Antonio Kidney Disease Center
    San Antonio, Texas 78216, United States
  • Richmond Vascular Center
    North Chesterfield, Virginia 23236, United States
08

References and documents

Study documents

  • Study protocol · Oct 13, 2022
  • Statistical analysis plan · Feb 15, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT04484220
Lead sponsor
Medtronic Endovascular
Responsible party
Sponsor
First posted
Jul 23, 2020
Start date
Apr 13, 2021
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025
Results posted
May 7, 2026
Last update
Jun 1, 2026

Study contacts

Haimanot Wasse, MD
principal investigator · Rush University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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