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

Laminate Medical Technologies

Status: Completed

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

Treatments: Device: VasQ

Study type: Interventional

Funder types: Industry

Identifiers

NCT03246984

CD0097

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

VasQ device implantation

Experimental group

Treatment:

Device: VasQ