VasQ External Support for Arteriovenous Fistula (NCT03242343) | Clinical Trial Compass
CompletedNot Applicable
VasQ External Support for Arteriovenous Fistula
United States144 participantsStarted 2017-11-29
Plain-language summary
This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow.
All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Main study cohort: Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study and which are not indicated for a more distal fistula per treatment guidelines.
✓. Male and female participants.
✓. Age 18-80 years.
✓. Patients willing and able to attend follow up visits over a period of 24 months.
Exclusion criteria
✕. Patients with the planned index procedure being a revision surgery of an existing fistula.
✕. Main study cohort: Target artery smaller than 2.5 mm or larger than 6 mm in inner diameter by preoperative ultrasound.
✕. Main study cohort: Target vein smaller than 2.5 mm in inner diameter by preoperative ultrasound.
✕. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the area between the planned anastomosis site and the Axillary vein.)
✕. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
✕. Patients with central venous stenosis or obstruction on the side of surgery.
✕. Depth of vein greater than 8 mm (on ultrasound) on side of surgery.
✕
What they're measuring
1
Primary Patency of AVF
Timeframe: 6 months post AVF creation
2
Occurrence of safety events
Timeframe: Device implantation to 6 months post AVF creation