Renal Disease, End StageNCT04484220

Ellipsys Vascular Access System Post Market Surveillance (PS) Study

A study testing Ellipsys Vascular Access System in people with Renal Disease, End Stage and Kidney Disease, End-Stage, run by Medtronic Endovascular at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Renal Disease, End Stage, Kidney Disease, End-Stage, AV Fistula
What is being tested?: Ellipsys Vascular Access System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 12 sitesUnited States
Study dates: 13 Apr 2021to 31 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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Confirmed clinically significant outflow
Adequate quality radial artery based on pre-operative assessment
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
Imaging-based Inclusion Criteria:
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

Who cannot join

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

Show all 16Show fewer

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
Patient has an active COVID-19 infection with ongoing sequela or hospitalization for treatment of COVID-19.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

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

Other trials in United States

About this study

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

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.

Conditions: Renal Disease, End Stage, Kidney Disease, End-Stage, AV Fistula, Fistulas Arteriovenous
Being tested: Ellipsys Vascular Access System
Medical subject headings: Kidney Failure, Chronic, Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ellipsys Vascular Access SystemDevice
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.

Study groups in NCT04484220
Study group	Role	What they receive
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. Receives: Device: Ellipsys Vascular Access System

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative Patency Through 12 Months Post-AVF Creation
Freedom from access abandonment from time of access creation
Measured: 12 months post-procedure
Early Occlusion Rate at 7 Days
Percent of patients with total occlusion within 7 days of the AVF creation procedure
Measured: 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.
Measured: 12 months post-procedure

Secondary outcomes (5)

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
Measured: 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
Measured: 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).
Measured: 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
Measured: 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)
Measured: 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 202131 Mar 2025

First posted23 Jul 2020
Study start13 Apr 2021
Primary completion31 Mar 2025
Study completion31 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal Disease, End StageStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04484220
Sponsor's protocol ID: PS200001
Status last verified: May 2026
First submitted: 25 Jun 2020
Last updated: 1 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Disease, End Stage trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ellipsys Vascular Access System Post Market Surveillance (PS) Study PS200001 Reference DEN170004
ClinicalTrials.gov ID: NCT04484220
Acronym / sponsor ID: PS200001
Conditions: Renal Disease, End Stage, Kidney Disease, End-Stage, AV Fistula, Fistulas Arteriovenous
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Medtronic EndovascularIndustry (pharma, biotech, devices)
Study start: 13 Apr 2021 (actual)
Primary completion: 31 Mar 2025 (actual)
Study completion: 31 Mar 2025 (actual)
First posted: 23 Jul 2020 (actual)
Results: Posted 7 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ellipsys Vascular Access System	Experimental	Device: Ellipsys Vascular Access SystemThe 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 may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ellipsys Vascular Access SystemThe 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.	Device	Ellipsys Vascular Access System

Primary outcome

Cumulative Patency Through 12 Months Post-AVF Creation
Time frame: 12 months post-procedure
Freedom from access abandonment from time of access creation
Early Occlusion Rate at 7 Days
Time frame: 7 days post-procedure
Percent of patients with total occlusion within 7 days of the AVF creation procedure
Study Related Serious Adverse Event (SAE) Rate Through 12 Months
Time frame: 12 months post-procedure
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.

5 secondary outcomes

Primary Patency Through 12 Months Post-AVF Creation
Time frame: 12 months post-procedure
Assisted Primary Patency Through 12 Months Post-AVF Creation
Time frame: 12 months post-procedure
Secondary Procedures Rate, Per Person Years
Time frame: 12 months post-procedure
Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events
Time frame: 12 months post-procedure
Secondary Procedures Rate, Percentage of Subjects
Time frame: 12 months post-procedure

Results and safety

Results posted to the registry on 7 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ellipsys Vascular Access System	142	98

Primary outcome: Cumulative Patency Through 12 Months Post-AVF Creation

Time frame: 12 months post-procedure. Number (95% Confidence Interval). Unit: Probability as a percentage

Measure	Ellipsys Vascular Access System n = 131
Value	99.1 (97.4 to 100)

Population analysed: Cumulative patency is defined as freedom from access abandonment from time of access creation. Abandoned dialysis access is one that can no longer be used for 1 or 2- needle dialysis, it is unable to provide adequate blood flow and/or is unsafe for the patient, and the problem cannot be corrected by any intervention either medical, endovascular, or surgical. Cumulative patency is summarized for the treated pop. was reported by using the Kaplan-Meier survival estimate at 12 months, as a %.

Primary outcome: Early Occlusion Rate at 7 Days

Time frame: 7 days post-procedure. Number (97.5% Confidence Interval). Unit: Percentage of Subjects

Measure	Ellipsys Vascular Access System n = 131
Value	1.5 (0.4 to 6.3)

Population analysed: The primary safety endpoint of the Ellipsys PS study is early occlusion, defined as the percentage of subjects with a total occlusion within seven (7) days of the AVF creation procedure.

Primary outcome: Study Related Serious Adverse Event (SAE) Rate Through 12 Months

Time frame: 12 months post-procedure. Number (97.5% Confidence Interval). Unit: percentage of participants

Measure	Ellipsys Vascular Access System n = 131
Procedure related Post-market events with 97.5% CI	13.7 (8.3 to 21.8)
Procedure or Device related Serious Adverse Events Post-market events with 97.5% CI	12.2 (7.2 to 20.1)
UADE Post-market events with 97.5% CI	0 (0 to 3.7)

Population analysed: Numbers are % (number of subjects with at least one event/number of subjects in the safety population) unless otherwise stated.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: through 12 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ellipsys Vascular Access System	55 of 131 (42%)	3 of 131 (2.3%)	7 of 131

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Haimanot Wasse, MD principal investigator

Rush University Medical Center

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ellipsys Vascular Access System in people with Renal Disease, End Stage and Kidney Disease, End-Stage, run by Medtronic Endovascular at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Patency Through 12 Months Post-AVF Creation (time frame: 12 months post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04484220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.