Chronic Kidney DiseaseNCT02682420
everlinQ endoAVF Post Market Study
A study testing everlinQ endoAVF System in people with Chronic Kidney Disease, run by C. R. Bard at 11 sites in 3 countries.
Trial summary
Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- 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
- 100 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 20 Sep 2016to Aug 2019
- 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
- Adult (age >18 years old)
- Currently on chronic dialysis or expected to be started on chronic dialysis within 3 months of planned endoAVF creation
- Target treatment vein diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Venogram
- Target treatment artery diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Arteriogram
- Both radial and ulnar artery flow to the hand, as confirmed with Duplex Ultrasound and/or Allen's test (i.e.: palmar arch)
Who cannot join
- Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation
- Absence of perforator feeding the target cannulation vein(s) via Venogram
- Occlusion or stenosis >50% of target cannulation cephalic or basilic vein
- Significantly compromised (≥50% stenosis) flow in the treatment arm
- Documented ejection fraction (EF) ≤35% in the last 6 months
- Pregnant women
Show all 18Show fewer
- New York Heart Association (NYHA) class III or IV heart failure
- Hypercoagulable state
- Known bleeding diathesis
- 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
- 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
- Evidence of active infections on the day of the index procedure
- Estimated life expectancy < 1 year
- Patient is not willing to provide written informed consent, is not geographically stable and/or not willing to comply with required follow-up
- Patient with a target cannulation vein that is > 6mm deep that would require a transposition procedure, defined as the elevation of a target cannulation vein AND the creation of a new AV fistula
- Patient is not willing to undergo a 2nd stage procedure as defined in Section 4.5.3 of the study protocol.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Germany6 sites
University Hospital Carl Gustav Carus
Dresden
Dominikus Hospital
Düsseldorf
University of Frankfurt
Frankfurt
University of Leipzig
Leipzig
University of Mannheim
Mannheim
St. Franziskus-Hospital Münster
Münster
United Kingdom4 sites
University Hospitals Birmingham
Birmingham
Oxford University Hospitals - NHS Foundation Trust
Headington, Oxford, OX3 9DU
St. George's University
London
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Canada1 site
Providence Health Care Society
Vancouver, British Columbia, V6Z 2K5
About this study
Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for hemodialysis.
- Conditions
- Chronic Kidney Disease
- 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 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.
Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure
Primary patency was defined in this study as "The interval from the time of access placement until any intervention designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time of measurement of patency".
Measured: endoAVF creation through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start20 Sep 2016
- Primary completionAug 2019
- Study completionAug 2019
Why it stopped: Company acquisition
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 DiseaseStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Inston, MD, Principal investigator, University Hospitals Birmingham NHSThomas Schmitz-Rixen, MD, Principal investigator, Univerisity of Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682420
- Sponsor's protocol ID
- CD-0018
- Status last verified
- Nov 2025
- First submitted
- 5 Feb 2016
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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 endoAVF Post Market Study
- ClinicalTrials.gov ID
- NCT02682420
- Acronym / sponsor ID
- CD-0018
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company acquisition
- Enrolment
- 100 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Posted 17 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for hemodialysis.
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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (age >18 years old)
- Currently on chronic dialysis or expected to be started on chronic dialysis within 3 months of planned endoAVF creation
- Target treatment vein diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Venogram
- Target treatment artery diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Arteriogram
- Both radial and ulnar artery flow to the hand, as confirmed with Duplex Ultrasound and/or Allen's test (i.e.: palmar arch)
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
- Absence of perforator feeding the target cannulation vein(s) via Venogram
- Occlusion or stenosis >50% of target cannulation cephalic or basilic vein
- Significantly compromised (≥50% stenosis) flow in the treatment arm
- Documented ejection fraction (EF) ≤35% in the last 6 months
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
Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure
Time frame: endoAVF creation through 6 months
Primary patency was defined in this study as "The interval from the time of access placement until any intervention designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time of measurement of patency".
Results and safety
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.
- 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.
Nicholas Inston, MD principal investigator
University Hospitals Birmingham NHS
Thomas Schmitz-Rixen, MD principal investigator
Univerisity of Frankfurt, Germany
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing everlinQ endoAVF System in people with Chronic Kidney Disease, run by C. R. Bard at 11 sites in 3 countries.
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 5 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: stopped early, 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 11 sites in Germany, United Kingdom, Canada. 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 17 Nov 2021). 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?
Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure (time frame: endoAVF creation through 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.