Phase 3
N=269
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
Complication of Renal Dialysis · End Stage Renal Disease · End Stage Kidney Disease · ESRD · Chronic Kidney Failure
Bottom Line
View on ClinicalTrials.gov: NCT02513303 ↗Enrolled (actual)
269
Serious AEs
46.8%
Results posted
Oct 2025
Primary outcome: Primary: Fistula Suitability for Dialysis at 6 Months (FSD6) — 74; 76; 21; 43 Participants — p=0.2942
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sirolimus (Drug); AV Fistula Surgery (Procedure); Sirolimus-eluting Collagen Implant (SeCI) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vascular Therapies, Inc.
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fistula Suitability for Dialysis at 6 Months (FSD6) |
74; 76; 21; 43; 35; 5 | 0.2942 |
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02513303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.