everlinQ endoAVF Post Market Study

TVA Medical

Status

Terminated

Conditions

Chronic Kidney Disease

Treatments

Device: everlinQ endoAVF System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02682420

CD-0018

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.