VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess t… (NCT03246984) | Clinical Trial Compass
CompletedNot Applicable
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
France, Germany80 participantsStarted 2017-09-07
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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.