Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-03-14 @ 10:40 PM
Study NCT ID:
NCT02112669
Status:
COMPLETED
Last Update Posted:
2019-06-06
First Post:
2014-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas
Sponsor:
Laminate Medical Technologies
Organization:
Study Overview
Official Title:
A Prospective, Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Brachiocephalic Arteriovenous Fistula
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: