An interventional study of VasQ and Arteriovenous fistula creation for dialysis vascular access in End Stage Renal Disease, sponsored by Laminate Medical Technologies. Recruiting at 9 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Laminate Medical Technologies · Not applicable, Interventional, and Prevention
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:
Structure
This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms:
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?
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 300 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Laminate Medical Technologies is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receiving an end to side arteriovenous fistula, supported by VasQ, for fistula access
Device: VasQ · Procedure: Arteriovenous fistula creation for dialysis vascular access
Patients receiving an end to side arteriovenous fistula, for fistula access
Procedure: Arteriovenous fistula creation for dialysis vascular access
External support implant for the arteriovenous fistula
End to side fistula creation in the arm for dialysis vascular access
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
Safety - vascular access related complications
Comparable rate of access related complications (including major reintervention and cannulation related complications)
Time frame: 1 year
Plan to share: No
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Laminate Medical Technologies