NCT02513303

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

A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Vascular Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Complication of Renal Dialysis
• End Stage Renal Disease
• End Stage Kidney Disease
• ESRD
• Chronic Kidney Failure
• Complication of Hemodialysis
• Vascular Access Complication
• Arteriovenous Fistula

Interventions

Type	Name	Description
DRUG	Sirolimus	A single dose of sirolimus delivered locally
PROCEDURE	AV Fistula Surgery	AV Fistula Surgery
DEVICE	Sirolimus-eluting Collagen Implant (SeCI)	SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.

Timeline

• Start date: 2015-11-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2015-07-31
• Last updated: 2025-10-09
• Results posted: 2025-10-09

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study