everlinQ endoAVF Post Market Study

NCT02682420 | Terminated Results

• 1 other identifier: CD-0018
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 11

Brief 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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Participants With Assisted Primary Patency of the endoAVF at 6 Months Post-Index Procedure

  endoAVF creation through 6 Months

• Participants With Secondary Patency of the endoAVF at 6 Months Post-Index Procedure

  endoAVF creation through 6 Months

• Participants With Functional Patency of the endoAVF at 6 Months Post-Index Procedure

  endoAVF creation through 6 Months

Study Arms (1)

endoAVF

OTHER

Device: everlinQ endoAVF System

Interventions

everlinQ endoAVF System DEVICE

endoAVF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (11)

Providence Health Care Society

Vancouver, British Columbia, V6Z 2K5, Canada

Location

University Hospital Carl Gustav Carus

Dresden, Germany

Location

Dominikus Hospital

Düsseldorf, Germany

Location

University of Frankfurt

Frankfurt, Germany

Location

University of Leipzig

Leipzig, Germany

Location

University of Mannheim

Mannheim, Germany

Location

St. Franziskus-Hospital Münster

Münster, Germany

Location

Oxford University Hospitals - NHS Foundation Trust

Headington, Oxford, OX3 9DU, United Kingdom

Location

University Hospitals Birmingham

Birmingham, United Kingdom

Location

St. George's University

London, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was discontinued prior completion due to company acquisition. Therefore, the full analysis was completed at the 6-month time point for all remaining participants. Data collection and data management was completed by a third party contractor independent of the sponsor. Statistical analysis was completed per protocol by an independent statistician.

Results Point of Contact

• Title: Courtney Rothwell, Clinical Project Manager
• Organization: BD Peripheral Intervention

courtney.rothwell@bd.com

602-830-5544

Study Officials

• Nicholas Inston, MD

  University Hospitals Birmingham NHS

  PRINCIPAL INVESTIGATOR

• Thomas Schmitz-Rixen, MD

  Univerisity of Frankfurt, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 15, 2016
• Study Start: September 20, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: December 11, 2025
• Results First Posted: November 17, 2021

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); GB (4); DE (6)