everlinQ endoAVF Post Market Study

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.

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.