everlinQ endoAVF Post Market Study

Study Overview
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Brief Summary
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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.

Official Title
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everlinQ endoAVF Post Market Study

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Device: everlinQ endoAVF System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: endoAVF<br> | Device: everlinQ endoAVF System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure | 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. | endoAVF creation through 6 months |