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

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).

Timeline

Start

2015-11

Primary completion

2021-06

Completion

2021-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Sirogen vs Control; p = 0.2942; Regression, Logistic NCT02513303 ↗

Drugs

Indications