Last updated on April 2018

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


Brief description of study

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.

Clinical Study Identifier: NCT02513303

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Rakesh Raghubanshi

Nephrology Consultants, LLC
Huntsville, AL United States
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Rakesh Raghubanshi

AKDHC Medical Research Service
Phoenix, AZ United States
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Rakesh Raghubanshi

San Diego Institute of Medical Research
Escondido, CA United States
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Rakesh Raghubanshi

Northeast Clinical Research Center
Bethlehem, PA United States
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