A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas

Laminate Medical Technologies

Status

Completed

Conditions

Vascular Access

End Stage Renal Disease

Treatments

Device: VasQ

Study type

Interventional

Funder types

Industry

Identifiers

NCT02112669

Laminate CD0006

Details and patient eligibility

About

This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. These geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence and promote laminar flow. The device is designed to improve short term maturation and long term patency of the fistula. The VasQ is a permanent implant intended for use as a subcutaneous arteriovenous conduit support for vascular access.

Enrollment

60 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study.
Aged > 18
Male and female participants
Patients willing and able to attend follow up visits over a period of 6 months

Exclusion criteria

Patients who require revision surgery.
Having had previous arteriovenous fistula surgery is not a contraindication to recruitment provided the new procedure is not revision surgery
Target arteries smaller than 3 mm in diameter
Target vein smaller than 3 mm in diameter
Stenotic veins on the side of surgery as diagnosed on pre-op ultrasound
Patients with prior central venous stenosis or obstruction on the side of surgery
Depth of vein greater than 8 mm (on US) on side of surgery
Known coagulation disorder
Prior steal
Known allergy to nitinol
Life expectancy less than 6 months
Inability to give consent and/or comply with the study follow up schedule
Women of child bearing age