Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
Completed · Phase 3
Conditions studied: Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD, Chronic Kidney Failure, Complication of Hemodialysis, Vascular Access Complication, Arteriovenous Fistula
In brief
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).
Key facts
- Study ID
- NCT02513303
- Run by
- Vascular Therapies, Inc.
- People needed
- 269
- Starts
- 2015-11-01
- Expected to finish
- 2021-06-01
- Last updated by the study team
- 2025-10-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Currently on hemodialysis for ≤12 months or expected to initiate hemodialysis within approximately 6 months of the creation of the AV fistula.
- Vascular anatomy suitable for creation of the AV fistula, determined by pre procedure duplex ultrasound
- Successful creation of a single stage radiocephalic or brachiocephalic end to side fistula
You may not qualify if…
- Prior AV access created on the limb where the fistula surgery is planned
- ST-elevation MI or cerebrovascular accident within 30 days of the index procedure
- Known hypersensitivity to the following: sirolimus, beef or bovine collagen
- Hypotension with systolic blood pressures <100 mm Hg at the time of screening
- Known or suspected active infection at the time of the AV fistula surgery
- Known to be HIV positive
- Prisoner, mentally incompetent, and/or alcohol or drug abuser
Where it is running
- Nephrology Consultants, LLC — Huntsville, Alabama, United States
- AKDHC Medical Research Service — Phoenix, Arizona, United States
- San Diego Institute of Medical Research — Escondido, California, United States
- Northeast Clinical Research Center — Bethlehem, Pennsylvania, United States
Full record on ClinicalTrials.gov
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