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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2021-06-30

Brief Summary

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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).

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Treatment Group

AV fistula surgery Single administration of sirolimus-eluting Collagen implant

Group Type EXPERIMENTAL

Sirolimus

Intervention Type DRUG

A single dose of sirolimus delivered locally

AV Fistula Surgery

Intervention Type PROCEDURE

AV Fistula Surgery

Sirolimus-eluting Collagen Implant (SeCI)

Intervention Type DEVICE

SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.

Control Group

AV fistula surgery

Group Type OTHER

AV Fistula Surgery

Intervention Type PROCEDURE

AV Fistula Surgery

Interventions

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Sirolimus

A single dose of sirolimus delivered locally

Intervention Type DRUG

AV Fistula Surgery

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Other Intervention Names

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Rapamycin Rapamycin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No