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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Sheba Medical Center
Ramat Gan, Israel
Southmead Hospital
Bristol, United Kingdom
Guy's Hospital
London, United Kingdom
St George's Healthcare
London, United Kingdom
Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events
Time frame: 6 months
Secondary efficacy endpoint: Percentage of AVF physiologically matured
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
Time frame: 3 months
Secondary efficacy endpoint: Primary patency of the study AVF, defined as percentage of patent AVF free from surgical or endovascular interventions
Time frame: 6 months
Secondary efficacy endpoint: Cephalic vein outflow as assess with Doppler ultrasound
Time frame: 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
Time frame: 6 months
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