NCT02112669

A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas

A Prospective, Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Brachiocephalic Arteriovenous Fistula

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Laminate Medical Technologies · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. These geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence and promote laminar flow. The device is designed to improve short term maturation and long term patency of the fistula. The VasQ is a permanent implant intended for use as a subcutaneous arteriovenous conduit support for vascular access.

Conditions

• Vascular Access
• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	VasQ

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2014-04-14
• Last updated: 2019-06-06

Locations

4 sites across 2 countries: Israel, United Kingdom