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

Study Overview
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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).

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.

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

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

Intervention / Treatment
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* Drug: Sirolimus
* Procedure: AV Fistula Surgery
* Device: Sirolimus-eluting Collagen Implant (SeCI)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>AV fistula surgery Single administration of sirolimus-eluting Collagen implant | Drug: Sirolimus<br>* A single dose of sirolimus delivered locally<br>* Other names: Rapamycin;Procedure: AV Fistula Surgery<br>* AV Fistula Surgery<br>Device: Sirolimus-eluting Collagen Implant (SeCI)<br>* SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.<br>* Other names: Rapamycin;|
| Other: Control Group<br>AV fistula surgery | Procedure: AV Fistula Surgery<br>* AV Fistula Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula Suitability for Dialysis at 6 Months (FSD6) | For subjects who are on hemodialysis by day 150, suitability for dialysis will be determined by the ability to use the fistula for dialysis using 2-needles with a mean dialysis machine blood pump speed of ≥300 mL/min for two-thirds of the dialysis sessions during a 30 day suitability ascertainment period that begins 150 days after fistula creation. For subjects who are not on hemodialysis on day of enrollment and who do not initiate hemodialysis by day 150, suitability for dialysis will be determined by a vascular ultrasound performed at the 6 month follow up visit. Suitability for dialysis will be defined as a fistula with an access vein diameter (AVD) of ≥6 mm (internal diameter) and an access blood flow of ≥500 mL/min. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD, Chronic Kidney Failure, Chronic Renal Failure, Chronic Kidney Disease, Hemodialysis, Vascular Access, Arteriovenous Fistula, AV Fistula, AVF, Nephrology, Vascular Surgery, Dialysis Access