Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.
Laminate Medical Technologies
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
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 compara…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ IFU and investigator clinical judgment) and consent to take part in the study. 2. Male and non-pregnant female participants. 3. Age 18-80 years 4. Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months. Exclusion Criteria: 1. Index procedure being a revision surgery of an existing fistula. 2. Significantly stenotic target vein on the side of surgery (≥50%) as diagno…
Interventions
- DeviceVasQ
External support implant for the arteriovenous fistula
- ProcedureArteriovenous fistula creation for dialysis vascular access
End to side fistula creation in the arm for dialysis vascular access
Locations (7)
- Fresenius Vascular Care Long BeachLong Beach, California
- Sarasota Memorial HospitalSarasota, Florida
- Brigham and Women's HospitalBoston, Massachusetts
- Greenwood Leflore HospitalGreenwood, Mississippi
- Azura Surgery Center Las VegasLas Vegas, Nevada
- Fresenius Vascular Care ColumbiaColumbia, South Carolina