VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ

Study Overview
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Brief Summary
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This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.

Official Title
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A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula

Conditions
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Arterio-Venous Fistula, Kidney Failure, Chronic, Kidney Diseases, Renal Failure Chronic, ESRD, Arteriovenous Fistula Thrombosis

Intervention / Treatment
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* Device: VasQ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for creation of a new brachiocephalic or radiocephalic fistula who consent to take part in the study. Age 18-80 years Male and female participants Patients willing and able to attend follow up visits over a period of 12 months Exclusion Criteria: Patients with the planned index procedure being a revision surgery of an existing fistula. Target Brachial artery smaller than 2.5 mm or larger than 6 mm or Radial artery smaller than 2.5 mm or larger than 4 mm in outer diameter by preoperative ultrasound Target vein outer diameter smaller than 2.5 mm by preoperative ultrasound Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on pre-op ultrasound (scan should include the area between the planned anastomosis site and the Axillary vein) Unusual anatomy or vessel dimensions (observed on pre-operative US or intraoperatively) and which preclude adequate fit of the VasQ. Patients with prior central venous stenosis or obstruction on the side of surgery Depth of vein greater than 8 mm (on ultrasound) on side of surgery Known coagulation disorder Congestive heart failure NYHA class ≥ 3 Prior steal on the side of surgery as evident from the patient's medical history Known allergy to nitinol Life expectancy less than 18 months Patients expected to undergo kidney transplant within 6 months of enrollment Women of child bearing potential without documented current negative pregnancy test Inability to give consent and/or comply with the study follow up schedule

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: VasQ device implantation<br> | Device: VasQ<br>* VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency of AV fistula | Freedom from any intervention designed to maintain or reestablish patency since device placement and demonstrate flow on Doppler US. 1 = Success = Intervention free access patency determined by Doppler ultrasound. 0 = Failure = Access occluded determined by Doppler ultrasound and/or underwent intervention | 6 months post AVF creation |