everlinQ endoAVF Post Market Study

Not Applicable

Terminated

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
endoAVF	everlinQ endoAVF System	-

Primary Outcome Measures

Name	Time	Method
Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure	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".

Secondary Outcome Measures

Name	Time	Method

Locations (11): Providence Health Care Society
🇨🇦
Vancouver, British Columbia, Canada
St. George's University
🇬🇧
London, United Kingdom
Oxford University Hospitals - NHS Foundation Trust
🇬🇧
Headington, Oxford, United Kingdom
University Hospitals Birmingham
🇬🇧
Birmingham, United Kingdom
University Hospital Carl Gustav Carus
🇩🇪
Dresden, Germany
St. Franziskus-Hospital Münster
🇩🇪
Münster, Germany
Manchester University NHS Foundation Trust
🇬🇧
Manchester, United Kingdom
University of Frankfurt
🇩🇪
Frankfurt, Germany
Dominikus Hospital
🇩🇪
Düsseldorf, Germany
University of Leipzig
🇩🇪
Leipzig, Germany
University of Mannheim
🇩🇪
Mannheim, Germany