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Chronic Kidney DiseasesNCT03708562

everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

A study testing everlinQ endoAVF System in people with Chronic Kidney Diseases, run by C. R. Bard at 1 site in Paraguay.

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

Prospective, single-center study to evaluate the everlinQ endoAVF System when used to create an endoAVF in hemodialysis patients. This study aims to investigate expansion of the percutaneous venous access location to the superficial system which may provide additional procedural benefit. Read more about this study

Who is it for?
Ages 18 years and older
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
24 participants
Where
1 siteParaguay
Study dates
16 Oct 2017to 12 Dec 2018
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 years and older
  • 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) at fistula site ≥ 2.0 mm.
  • Target artery diameter at fistula site ≥ 2.0 mm.
  • Procedural access site artery and vein diameter ≥ 2.0 mm.
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  • At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the perforating vein.
  • 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.
  • Presence of an antecubital perforating vein diameter ≥ 2.0 mm.

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 the 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.
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  • 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.
  • Known adverse effects to sedation and/or anesthesia which cannot be adequately pre- medicated.
  • Patients who do not have an ulnar or radial artery.
  • Distance between target artery and vein or other anatomical abnormality will not permit catheters to be introduced, navigated to fistula site, or allow magnets to align vessels sufficiently to create the fistula.
  • Evidence of calcification in vessels at the fistula site.
  • Evidence of active infections on the day of the index procedure.
  • Written informed consent not obtained.

Trial locations and contacts

1 site in 1 country.

Paraguay1 site

  • Sanatorio Italiano

    Asunción

Other trials in Paraguay

About this study

Prospective, single-center study to evaluate the everlinQ endoAVF System when used to create an endoAVF in hemodialysis patients. This study aims to investigate expansion of the percutaneous venous access location to the superficial system which may provide additional procedural benefit.

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 may be followed for up to 12 months post index procedure based on Investigator's discretion. The duration of the study is expected to be approximately two (2) years.

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

    The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.

Study groups in NCT03708562
Study groupRoleWhat they receive
endoAVFOtherNot described
Receives: Device: everlinQ endoAVF System

What is being measured

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

  1. Number of Participants With Procedural Success

    Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure.

    Measured: At time of procedure

  2. Adverse Event Rate

    Percentage of patients who experience one or more adverse events during the first 3 months following successful endoAVF creation. Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC).

    Measured: 3 months following endoAVF creation

Secondary outcomes (9)

  1. Percentage of Participants With Primary Patency at 6 Months Post Index Procedure

    Primary Patency was defined as the time interval between the endoAVF index procedure and the earlier of a) any intervention designed to maintain or reestablish patency, b) access thrombosis, or c) access abandonment. Kaplan-Meier (KM) was used to analyze the data.

    Measured: 6 months post index procedure

  2. Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure

    Maturity of the endoAVF was defined by duplex ultrasound criteria, as described in the literature as a useful surrogate of suitability for dialysis. Maturation was defined as duplex ultrasound flow in the brachial artery of at least 500 ml/min and a vein diameter ≥ 4mm, without significant stenosis or thrombosis. If a subject was on hemodialysis, maturity was defined by successful dialysis with 2-needles at least once.

    Measured: 1, 3, and 6 months post index procedure

  3. Time to Cannulation (Months)

    The interval of time from the index procedure to successful 2-needle cannulation of the endoAVF.

    Measured: Months from index procedure to cannulation

  4. Number of Participants With Cannulation Success at Defined Follow-up Intervals

    A subject was referred to as a 'cannulation success' with the first successful 2-needle cannulation of the endoAVF access circuit. "Cannulation Success" was defined by at least one successful hemodialysis session through a 2-needle cannulation of the endoAVF access circuit. "Cumulative Cannulation Success" = (Successes Through End Current Interval) / (Subjects on Dialysis at Start Current Interval + Censored Dialysis Subjects through End of Last Interval).

    Measured: 0-10 days, 11-45 days, 46-135 days, 136-210 days post index procedure

  5. Percentage of Participants With Assisted Primary Patency at 6 Months

    Defined as the interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion.

    Measured: 6 months post index procedure

  6. Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure

    Secondary Patency was defined as the time interval between the endoAVF index procedure and a) access abandonment, or b) loss to thrombosis, irrespective of intervening surgical or endovascular interventions designed to re-establish functionality in a stenosed or thrombosed access circuit.

    Measured: 6 months post index procedure

  7. Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure

    The interval of time from the first 2-needle dialysis utilizing the access until access abandonment (SVS Reporting Standards definition). Functional Patency was the interval of time from the first 2-needle dialysis of the endoAVF access circuit until access abandonment.

    Measured: 6 months post index procedure

  8. Number of Participants With EndoAVF Related Reintervention

    The re-intervention rate for endoAVF (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

  9. Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure

    Modified Primary Patency was defined as a measure of patency that, in addition to occlusion or reinterventions within the access circuit, also included coil embolization or open surgical ligation of outflow venous branches as failures of patency when they occur after the index procedure.

    Measured: 6 months post index procedure

Timeline

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

  1. First posted17 Oct 2018
  2. Study start16 Oct 2017
  3. Primary completion12 Dec 2018
  4. Study completion12 Dec 2018

Resources

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03708562
Sponsor's protocol ID
CD-0038
Status last verified
Nov 2025
First submitted
13 Oct 2018
Last updated
11 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 at 1 site in Paraguay.

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 10 inclusion and 19 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.

Where is the study taking place?

The record lists 1 site in Paraguay. 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 2 Jan 2020). 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 Procedural Success (time frame: At time of 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 NCT03708562.

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.

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