everlinQ endoAVF Post Market 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.

Study Overview

• Status: Terminated
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Device: everlinQ endoAVF System

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • Providence Health Care Society
• Germany
  • Dresden, Germany
    • University Hospital Carl Gustav Carus
  • Düsseldorf, Germany
    • Dominikus Hospital
  • Frankfurt, Germany
    • University of Frankfurt
  • Leipzig, Germany
    • University of Leipzig
  • Mannheim, Germany
    • University of Mannheim
  • Münster, Germany
    • St. Franziskus-Hospital Münster
• United Kingdom
  • Birmingham, United Kingdom
    • University Hospitals Birmingham
  • London, United Kingdom
    • St. George's University
  • Manchester, United Kingdom, M13 9WL
    • Manchester University NHS Foundation Trust
  • Oxford
    • Headington, Oxford, United Kingdom, OX3 9DU
      • Oxford University Hospitals - NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: endoAVF	Device: everlinQ endoAVF System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	endoAVF creation through 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Assisted Primary Patency of the endoAVF at 6 Months Post-Index Procedure	Assisted Primary Patency was defined in this study as "The interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion".	endoAVF creation through 6 Months
Participants With Secondary Patency of the endoAVF at 6 Months Post-Index Procedure	Secondary Patency in this study was defined as "The interval from the time of access placement until access abandonment, loss to thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access".	endoAVF creation through 6 Months
Participants With Functional Patency of the endoAVF at 6 Months Post-Index Procedure	Functional Patency in this study was defined as "The interval of time from the first 2-needle dialysis utilizing the access until access abandonment".	endoAVF creation through 6 Months
Number of Days Post-Index Procedure for Participants to Achieve Successful Cannulation of the endoAVF	The time (number of days) from the index procedure (successful endoAVF creation) to the first use of the endoAVF. This endpoint is evaluated per participant rather than at specific time points.	endoAVF creation to cannulation
Number of Participants With Procedural Success at the Index Procedure	The successful creation of an endoAVF with blood flow confirmed intraoperatively by fistulography or by duplex ultrasound postoperatively. This outcome measure is assessed at the time of the endoAVF creation.	endoAVF creation
Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures)	The endoAVF-related interventions include: Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site.; Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins.; Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula.; Any intervention to address any complications or adverse events of the access circuit. This outcome measure is assessed at the time of the endoAVF creation.	endoAVF creation
Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions)	The endoAVF-related interventions include: Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site.; Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins.; Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula.; Any intervention to address any complications or adverse events of the access circuit.	endoAVF creation through 6 Months
Participants in Which endoAVF Maturation Was Achieved	Total time from successful endoAVF creation to one of the following: Successful hemodialysis using 2 needle cannulation OR; Vascular access that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least a 4.0 mm vein diameter as measured via duplex ultrasound. Note: 63 participants completed the 6-month visit. Participants who did not receive a duplex ultrasound and have not yet successfully dialyzed using 2 needle cannulation are not counted for this endpoint.	endoAVF creation through 6 months
Number of Participants That Were Not on Dialysis at endoAVF Creation and Are Central Venous Catheter (CVC) Free at Indicated Time Points	Number of participants that were not on dialysis at endoAVF creation and are central venous catheter (CVC) free at indicated time points.	endoAVF creation through 6 Months
Number of Participants That Experienced Device-related Serious Adverse Events Through 6 Months Post-Index Procedure	AE that: led to death,; led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,; led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the everlinQ endoAVF System	endoAVF creation through 6 Months
Number of Participants That Experienced Procedure-related Serious Adverse Events Through 6 Months Post-Index Procedure	AE that: led to death,; led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,; led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the index procedure	endoAVF creation through 6 Months

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Nicholas Inston, MD, University Hospitals Birmingham NHS; Principal Investigator: Thomas Schmitz-Rixen, MD, Univerisity of Frankfurt, Germany

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimated): February 15, 2016

Study Record Updates

• Last Update Posted (Estimated): December 11, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: CD-0018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO