Needle-Free blood vessel connection for dialysis patients tested
NCT ID NCT02682420
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a device called everlinQ endoAVF that creates a connection between an artery and a vein using a thin tube (catheter) instead of open surgery. The goal was to make it easier for people with chronic kidney disease to get dialysis. The trial enrolled 100 adults who needed or were about to start dialysis. However, the study was stopped early, so we don't have full results on how well it worked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- everlinQ endoAVF System (a device that creates a connection between an artery and vein using a catheter, avoiding open surgery)
- What this could lead to
- If successful, this device could provide a less invasive way to create dialysis access, potentially reducing surgery risks and recovery time.
- What could go wrong
- The trial was terminated early, so results are limited. The device may not work for all patients, and complications like clotting or narrowing of the fistula can still occur.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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100 people
The number who actually took part.
- Started
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Sep 2016
- Finished
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Aug 2019
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dominikus Hospital
Düsseldorf, Germany
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Manchester University NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
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Oxford University Hospitals - NHS Foundation Trust
Headington, Oxford, OX3 9DU, United Kingdom
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Providence Health Care Society
Vancouver, British Columbia, V6Z 2K5, Canada
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St. Franziskus-Hospital Münster
Münster, Germany
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St. George's University
London, United Kingdom
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University Hospital Carl Gustav Carus
Dresden, Germany
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University Hospitals Birmingham
Birmingham, United Kingdom
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University of Frankfurt
Frankfurt, Germany
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University of Leipzig
Leipzig, Germany
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University of Mannheim
Mannheim, Germany
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