everlinQ endoAVF EU Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Adult (age >18 years old)
2. Established, non-reversible kidney failure requiring hemodialysis (stage 4 or 5 renal disease) including pre-dialysis patients
3. Target treatment vein diameter(s) for fistula creation >= 2.0 mm as measured via Duplex Ultrasound or Venogram
4. Target treatment artery diameter >= 2.0 mm as measured via Duplex Ultrasound of Arteriogram
5. Both radial and ulnar artery flow to the hand

Exclusion Criteria

1. Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation
2. Absence of perforator feeding the target cannulation vein(s) via Venogram
3. Occlusion or stenosis >50% of target cannulation cephalic or basilic vein
4. Target cannulation vein that is >6 mm deep
5. Target cannulation vein that is <2.5 mm in diameter
6. Significantly compromised (>=50% stenosis) flow in the treatment arm as determined by physician and imaging
NOTE: patients that have >=50% arterial stenosis my undergo a Digital Brachial Index (DBI) test, if DBI result is <.65 patient is excluded
7. Documented ejection fraction (EF) <=35% in the last 6 months
8. Pregnant women
9. New York Heart Association (NYHA) class III or IV heart failure
10. Hypercoagulable state
11. Known bleeding diathesis
12. Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition
13. Documented history of drug abuse including intravenous drugs within six months of AVF creation
14. *Planned* concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment
15. Known allergy to contrast dye which cannot be adequately pre-medicated
16. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
17. Evidence of active infections on the day of the index procedure
18. Estimated life expectancy < 1 year
19. Patient is not willing to provide written informed consent, is not geographically stable and/or not willing to comply with required follow-up

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>All subjects that undergo successful endoAVF creation will contribute to the<br /><br>following outcome measures.<br /><br><br /><br>Primary Patency:<br /><br>Time of successful endoAVF creation until any intervention designed to maintain<br /><br>or reestablish patency or loss of endoAVF patency. The time to first<br /><br>intervention will be calculated as the number of days between the date of<br /><br>endoAVF creation and the date of either the first intervention, date of endoAVF<br /><br>abandonment, or date of last follow-up where patency was evaluated, whichever<br /><br>comes first.<br /><br><br /><br>Primary Assisted Patency:<br /><br>Time interval of successful endoAVF creation until first thrombosis (at<br /><br>endoAVF) causes loss of patency (thrombosis free survival). Interventions<br /><br>employed to keep the fistula usable whether open or surgical (including new<br /><br>anastomosis) do not affect this time.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Patency:<br /><br>Total time from successful endoAVF creation to complete abandonment. All<br /><br>subjects that undergo a successful endoAVF creation and do not have abandonment<br /><br>due to renal transplant receipt will be included in the outcome measurement.<br /><br><br /><br>Cumulative Functional Patency:<br /><br>The time period from first endoAVF cannulation (2 needle) to endoAVF<br /><br>abandonment.<br /><br><br /><br>Procedure Success:<br /><br>The successful endoAVF creation rate as assessed immediately post-procedure via<br /><br>fistulogram, duplex ultrasound, or via presence of thrill/bruit. All subjects<br /><br>that undergo the everlinQ procedure will contribute to this outcome measure.</p><br>