VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula
Structure This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula Duration The primary endpoint is defined at 6 month post index procedure of fistula creation. Patients will be further followed up to 12 months post index procedure. Main study question What is the magnitude of benefit of the VasQ device with regard to time to achieving a clinically functional AVF as compared to a comparable contemporary standard of care cohort?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
External support implant for the arteriovenous fistula
End to side fistula creation in the arm for dialysis vascular access
Fresenius Vascular Care Long Beach
Long Beach, California, United States
RECRUITINGSarasota Memorial Hospital
Sarasota, Florida, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
Fistula functional success
The time, in days, to the first day of a 28-day period in which the study fistula was able to be cannulated with two dialysis needles for at least 75% of dialysis sessions to achieve the prescribed dialysis
Time frame: 6 months
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Greenwood Leflore Hospital
Greenwood, Mississippi, United States
RECRUITINGAzura Surgery Center Las Vegas
Las Vegas, Nevada, United States
RECRUITINGFresenius Vascular Care Columbia
Columbia, South Carolina, United States
RECRUITINGFairlawn Surgery Center
Roanoke, Virginia, United States
RECRUITING