End Stage Renal Disease, Vascular Access
Conditions
Brief summary
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.
Interventions
DEVICEVasQ
Sponsors
Laminate Medical Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary efficacy endpoint: Percentage of AVF physiologically matured | 3 months | Successful physiological maturation was defined by a minimum of 5 mm cephalic vein diameter with volume outflow greater than 500 mL/min confirmed by color duplex spectral analysis |
| Secondary efficacy endpoint: Primary patency of the study AVF, defined as percentage of patent AVF free from surgical or endovascular interventions | 6 months | — |
| Secondary efficacy endpoint: Cephalic vein outflow as assess with Doppler ultrasound | 1, 3, and 6 months | — |
| Secondary efficacy endpoint: Secondary patency of the study AVF, defined as percentage of patent AVF following surgical or endovascular interventions | 6 months | — |
Countries
Israel, United Kingdom
Outcome results
None listed