NCT06516653

Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula

Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Laminate Medical Technologies · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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?

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	VasQ	External support implant for the arteriovenous fistula
PROCEDURE	Arteriovenous fistula creation for dialysis vascular access	End to side fistula creation in the arm for dialysis vascular access

Timeline

• Start date: 2025-01-13
• Primary completion: 2027-08-01
• Completion: 2028-05-01
• First posted: 2024-07-24
• Last updated: 2025-10-30

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study