Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04671771
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2020-12-05
Brief Title:
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access
Sponsor:
WLGore Associates
Organization:
WLGore Associates
Study Overview
Official Title:
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The CSP-2002 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft AVG when implanted in and used for hemodialysis in participants suffering from end-stage renal failure ESRD The InnAVasc AVG is implanted and used similar to other standard-of-care dialysis grafts currently on the market However the InnAVasc AVG has been uniquely designed to potentially allow for immediate needle access same day as implant surgery as opposed to 2-4 weeks of waiting to potentially reduce excessive bleeding from the graft after dialysis and it may provide protection from improper or missed needle cannulation attempts
Detailed Description:
The InnAVasc AVG is intended for use in ESRD hemodialysis patients who require HD and whose next most appropriate access is an AVG also including those who may require an immediate cannulation AVG
Patients with ESRD who require hemodialysis and are suitable for an AVG for hemodialysis access will be eligible for inclusion in the study Subjects will be implanted with an InnAVasc AVG in the forearm or upper arm using standard vascular surgical techniques The graft will be placed in a straight soft C configuration in the upper arm or looped configuration in the forearm forearm loop or upper arm axillary loop Placing the graft across the elbow will be prohibited Subjects must be able to be on antiplatelet therapy per the discretion of their physician ie aspirin clopidogrel etc
Patients with ESRD who require hemodialysis and are suitable for an AVG for hemodialysis access will be eligible for inclusion in the study Subjects will be implanted with an InnAVasc AVG in the forearm or upper arm using standard vascular surgical techniques The graft will be placed in a straight soft C configuration in the upper arm or looped configuration in the forearm forearm loop or upper arm axillary loop Placing the graft across the elbow will be prohibited Subjects must be able to be on antiplatelet therapy per the discretion of their physician ie aspirin clopidogrel etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None