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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-07

Study Completion Date

2021-01-11

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VasQ device implantation

Group Type EXPERIMENTAL

VasQ

Intervention Type DEVICE

VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.

Interventions

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VasQ

VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients referred for creation of a new brachiocephalic or radiocephalic fistula who consent to take part in the study.
2. Age 18-80 years
3. Male and female participants
4. Patients willing and able to attend follow up visits over a period of 12 months

Exclusion Criteria

1. Patients with the planned index procedure being a revision surgery of an existing fistula.
2. 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
3. Target vein outer diameter smaller than 2.5 mm by preoperative ultrasound
4. 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)
5. Unusual anatomy or vessel dimensions (observed on pre-operative US or intraoperatively) and which preclude adequate fit of the VasQ.
6. Patients with prior central venous stenosis or obstruction on the side of surgery
7. Depth of vein greater than 8 mm (on ultrasound) on side of surgery
8. Known coagulation disorder
9. Congestive heart failure NYHA class ≥ 3
10. Prior steal on the side of surgery as evident from the patient's medical history
11. Known allergy to nitinol
12. Life expectancy less than 18 months
13. Patients expected to undergo kidney transplant within 6 months of enrollment
14. Women of child bearing potential without documented current negative pregnancy test
15. Inability to give consent and/or comply with the study follow up schedule

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No