everlinQ Endovascular Access System Enhancements (EASE) Study

A study testing everlinQ endoAVF System in people with Chronic Kidney Diseases, run by C. R. Bard.

Completed

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

Trial summary

Prospective, single-center study to evaluate the everlinQ System when used to create an endoAVF in hemodialysis patients. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Chronic Kidney Diseases
What is being tested?: everlinQ endoAVF System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: No sites listed yet
Study dates: 27 Jul 2015to 19 Jun 2017
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 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Eligible for a native arteriovenous fistula.
Adult (age >18 years old).
Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients).
Target vein diameter(s) ≥ 2.0 mm or large enough to accommodate device diameter.
Target artery diameter ≥ 2.0 mm or large enough to accommodate device diameter.
Estimated life expectancy > 1 year.
Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure

Who cannot join

Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation.
Upper extremity venous occlusion(s) and/or vessel abnormality(ies) on the same side as the planned AVF creation that precludes endovascular AVF creation by everlinQ System as deemed by the interventionalists' clinical judgment.
Prior surgically created access in the planned treatment location.
Functioning surgical access in the planned treatment arm.
Pregnant women.
New York Heart Association (NYHA) class III or IV heart failure.

Show all 18Show fewer

Hypercoagulable state.
Known bleeding diathesis.
Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition.
Documented history of drug abuse including intravenous drugs within six months of AVF creation.
"Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment.
Currently being treated with another investigational device or drug.
Known allergy to contrast dye which cannot be adequately pre-medicated. CD-0015 Rev 02 - EASE Study Clinical Protocol CONFIDENTIAL Page 8 of 16
Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
Patients who do not have an ulnar or radial artery.
At the time of procedure distance between target artery and vein will not allow magnets to align vessels sufficiently to create the fistula.
Evidence of active infections on the day of the index procedure.
Written informed consent not obtained.

About this study

Prospective, single-center study to evaluate the everlinQ System when used to create an endoAVF in hemodialysis patients.

Read the detailed description

A total of up to 50 subjects will be enrolled and will undergo an endoAVF creation procedure using the everlinQ System. All subjects will be followed for up to 12 months post index procedure based on Investigator's discretion.

Conditions: Chronic Kidney Diseases
Being tested: everlinQ endoAVF System
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

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

everlinQ endoAVF SystemDevice

Study groups in NCT03708770
Study group	Role	What they receive
endoAVF	Other	Not described Receives: Device: everlinQ endoAVF System

What is being measured

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

Number of Participants With Protocol-Defined endoAVF Maturation
Protocol-defined endoAVF maturation is defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow at least 500ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR subject was dialized using 2 needles.
Measured: Through 6 months post-index procedure
Number of Participants With Device-Related SAEs
The safety Endpoint is protocol-defined as Device-Related SAE at 3 months.
Measured: 3 months following AVF creation

Secondary outcomes (6)

Number of Days to Fistula Maturation
Defined as the number of days between the date of AVF creation and the date of endoAVF maturation (based on primary efficacy endpoint definition of maturation).
Measured: Days from Index Procedure
Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure
Time from endoAVF creation until access abandonment. Abandonment due to renal transplant receipt was not included in this endpoint assessment.
Measured: 6 months post-index procedure
Primary Patency at 6 Months Post-index Procedure
Primary Patency is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site to maintain or reestablish patency or loss of endoAVF patency. The primary patency rate is determined via Kaplan-Meier methods and based on the time of endoAVF creation until any intervention designed to maintain or reestablish patnecy or endoAVF abandonment.
Measured: 6 months post-index procedure
Number of Participants Per Catheter Exposure Type
Number of participants with Central Venous Catheters (CVC), endoAVF only access, CVC + endoAVF access, and not reciving dialysis at 3 and 6 months post-index procedure.
Measured: 1-7 days, 30 days, 3, and 6 months post-index procedure
Number of Participants With Technical Success
Technical success is defined as verification that an endoAVF has been created and remains patent 1-7 days after the index procedure. Patency is determined by experienced examiner as the presence of a bruit that is detected with stethoscope, or presence of thrill, or via Duplex Ultrasound, or via angiogram.
Measured: 1-7 days following index-procedure
Number of Endo-AVF-related Re-interventions
The re-intervention rate for endo-AVF (defined as any intervention required to maintain or re-establish patency) was calculated at each available follow-up visit post-index procedure.
Measured: At 6 months follow-up

Timeline

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

27 Jul 201519 Jun 2017

First posted17 Oct 2018
Study start27 Jul 2015
Primary completion19 Jun 2017
Study completion19 Jun 2017

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 Chronic Kidney DiseasesStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03708770
Sponsor's protocol ID: CD-0015
Status last verified: Nov 2025
First submitted: 26 Jul 2018
Last updated: 11 Dec 2025
Results posted: Yes, on ClinicalTrials.gov

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?

Official record

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All Chronic Kidney Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: everlinQ Endovascular Access System Enhancements (EASE) Study
ClinicalTrials.gov ID: NCT03708770
Acronym / sponsor ID: CD-0015
Conditions: Chronic Kidney Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: 27 Jul 2015 (actual)
Primary completion: 19 Jun 2017 (actual)
Study completion: 19 Jun 2017 (actual)
First posted: 17 Oct 2018 (actual)
Results: Posted 14 Jun 2019

Clinical summary

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

Prospective, single-center study to evaluate the everlinQ System when used to create an endoAVF in hemodialysis patients.

Detailed description

Study design

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

Arm	Type	Receives
endoAVF	Other	Device: everlinQ endoAVF System

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Eligible for a native arteriovenous fistula.
Adult (age >18 years old).
Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients).
Target vein diameter(s) ≥ 2.0 mm or large enough to accommodate device diameter.
Target artery diameter ≥ 2.0 mm or large enough to accommodate device diameter.

Key exclusion criteria (18 listed)

Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation.
Upper extremity venous occlusion(s) and/or vessel abnormality(ies) on the same side as the planned AVF creation that precludes endovascular AVF creation by everlinQ System as deemed by the interventionalists' clinical judgment.
Prior surgically created access in the planned treatment location.
Functioning surgical access in the planned treatment arm.
Pregnant women.

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
everlinQ endoAVF System	Device	endoAVF

Primary outcome

Number of Participants With Protocol-Defined endoAVF Maturation
Time frame: Through 6 months post-index procedure
Protocol-defined endoAVF maturation is defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow at least 500ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR subject was dialized using 2 needles.
Number of Participants With Device-Related SAEs
Time frame: 3 months following AVF creation
The safety Endpoint is protocol-defined as Device-Related SAE at 3 months.

6 secondary outcomes

Number of Days to Fistula Maturation
Time frame: Days from Index Procedure
Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure
Time frame: 6 months post-index procedure
Primary Patency at 6 Months Post-index Procedure
Time frame: 6 months post-index procedure
Number of Participants Per Catheter Exposure Type
Time frame: 1-7 days, 30 days, 3, and 6 months post-index procedure
Number of Participants With Technical Success
Time frame: 1-7 days following index-procedure
Number of Endo-AVF-related Re-interventions
Time frame: At 6 months follow-up

Results and safety

Results posted to the registry on 14 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
endoAVF	32	22

Primary outcome: Number of Participants With Protocol-Defined endoAVF Maturation

Time frame: Through 6 months post-index procedure. Count of participants. Unit: Participants

Measure	endoAVF n = 32
Value	29

Primary outcome: Number of Participants With Device-Related SAEs

Time frame: 3 months following AVF creation. Count of participants. Unit: Participants

Measure	endoAVF n = 32
Value	0

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events (SAEs) were collected through 6-months post-index procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
endoAVF	2 of 32 (6.3%)	7 of 32 (21.9%)	5 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Kidney Diseases

RecruitingPhase 2
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Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
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Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
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Active, not recruitingPhase 4
A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing everlinQ endoAVF System in people with Chronic Kidney Diseases, run by C. R. Bard.

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 7 inclusion and 18 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 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

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 14 Jun 2019). 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?

Number of Participants With Protocol-Defined endoAVF Maturation (time frame: Through 6 months post-index procedure). The study lists 2 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 NCT03708770.

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 11 Dec 2025.