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Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes — ACCESS  

End Stage Renal Disease Clinical Trial

Official title:
A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant

Clinical Trial Summary

The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure).

Clinical Trial Description

The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure). Following successful creation of the AV fistula, the cohort randomized to the treatment group will receive the SeCI; the control group will not receive an implant. The primary hypothesis is that the proportion of subjects that meet requirements for fistula suitability for dialysis six months following the index procedure will be higher in the treatment group in comparison to the control group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02513303
Study type Interventional
Source Vascular Therapies, Inc.
Contact
Status Completed
Phase Phase 3
Start date November 2015
Completion date June 2021
View Details
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