Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
Start Date
1/13/2025
Completion Date
5/1/2028
Summary
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
Detailed Description
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?
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
VasQ
Arteriovenous fistula creation for dialysis vascular access
Conditions
Locations
Fresenius Vascular Care Long Beach
Long Beach, California 90706
United States
Sarasota Memorial Hospital
Sarasota, Florida 34239
United States
Grady Memorial Hospital
Atlanta, Georgia 30303
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Greenwood Leflore Hospital
Greenwood, Mississippi 38930
United States
Azura Surgery Center Las Vegas
Las Vegas, Nevada 99128
United States
Fresenius Vascular Care Columbia
Columbia, South Carolina 29203
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
Fairlawn Surgery Center
Roanoke, Virginia 24014
United States