Back to resultsTrial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes (ACCESS)
Primary Purpose
Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sirolimus
AV Fistula Surgery
Sirolimus-eluting Collagen Implant (SeCI)
Sponsored by
About this trial
This is an interventional prevention trial for Complication of Renal Dialysis focused on measuring 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
Eligibility 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
Sites / Locations
- Nephrology Consultants, LLC
- AKDHC Medical Research Service
- San Diego Institute of Medical Research
- Northeast Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Treatment Group
Control Group
Arm Description
AV fistula surgery Single administration of sirolimus-eluting Collagen implant
AV fistula surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02513303
Brief Title
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
Acronym
ACCESS
Official Title
A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Therapies, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD, Chronic Kidney Failure, Complication of Hemodialysis, Vascular Access Complication, Arteriovenous Fistula
Keywords
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
269 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
AV fistula surgery Single administration of sirolimus-eluting Collagen implant
Arm Title
Control Group
Arm Type
Other
Arm Description
AV fistula surgery
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
Rapamycin
Intervention Description
A single dose of sirolimus delivered locally
Intervention Type
Procedure
Intervention Name(s)
AV Fistula Surgery
Intervention Description
AV Fistula Surgery
Intervention Type
Device
Intervention Name(s)
Sirolimus-eluting Collagen Implant (SeCI)
Other Intervention Name(s)
Rapamycin
Intervention Description
SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.
Primary Outcome Measure Information:
Title
Fistula Suitability for Dialysis at 6 Months (FSD6)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sriram Iyer, MD
Organizational Affiliation
Vascular Therapies, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Nephrology Consultants, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
AKDHC Medical Research Service
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
San Diego Institute of Medical Research
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Northeast Clinical Research Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
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