This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow. All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
144
An external support device for AV fistula
Grandview Medical Center
Birmingham, Alabama, United States
Arizona Kidney Disease & Hypertension Center
Phoenix, Arizona, United States
Saint Francis Medical Center
Peoria, Illinois, United States
Lutheran Medical Group/Indiana Ohio Heart
Fort Wayne, Indiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Albany Medical College
Albany, New York, United States
Montefiore Medical Center
New York, New York, United States
Charlotte PA
Charlotte, North Carolina, United States
...and 5 more locations
Primary Patency of AVF
Proportion of patients with freedom from intervention since device placement
Time frame: 6 months post AVF creation
Occurrence of safety events
The occurrence per patient access related safety events
Time frame: Device implantation to 6 months post AVF creation
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