At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 269 enrolled
Drug / intervention
Sirolimus +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant
In Brief
A Phase 3 clinical trial evaluating Sirolimus, AV Fistula Surgery, and 1 other intervention for Complication of Renal Dialysis and 7 related conditions. Completed, enrolled 269 participants across 4 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD, Chronic Kidney Failure, Complication of Hemodialysis, Vascular Access Complication, Arteriovenous Fistula
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartNov 2015
Primary CompletionJun 2021
TodayJul 2026
First PostedJul 31, 2015
Enrollment StartNov 1, 2015
Primary CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 10.9 years ago
Interventions
Sirolimusdrug
A single dose of sirolimus delivered locally
AV Fistula Surgeryprocedure
AV Fistula Surgery
Sirolimus-eluting Collagen Implant (SeCI)device
SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.