everlinQ endoAVF Post Market Study

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.