Trial | NCT02513303  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sirolimus ...

  • Study Participants

    269
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).
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.
Study Started
Nov 30
2015
Primary Completion
Jun 30
2021
Study Completion
Jun 30
2021
Last Update
Jul 22
2021

Drug Sirolimus

A single dose of sirolimus delivered locally

  • Other names: Rapamycin

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.

  • Other names: Rapamycin

Treatment Group Experimental

AV fistula surgery Single administration of sirolimus-eluting Collagen implant

Control Group Other

AV fistula surgery

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
No Results Posted