A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
NCT ID: NCT05425056
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
136 participants
INTERVENTIONAL
2022-08-26
2025-08-29
Brief Summary
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Detailed Description
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Subjects of either gender, who are at least 65 years of age, undergoing hemodialysis, and require a new single stage radiocephalic end to side fistula will be eligible to participate in this study. Subjects who meet eligibility criteria and undergo successful AV fistula creation will be eligible for enrollment. The study plans to enroll approximately 120 subjects, randomized in a 1:1 ratio. Enrolled subjects will be followed for a period of one year from the time of their index surgical procedure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Treatment Arm
Subjects randomized to the treatment arm will undergo AV fistula surgery and will receive the Sirolimus eluting Collagen Implant (SeCI).
Sirolimus
SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.
Control Arm
Subjects randomized to the control arm will undergo AV fistula surgery alone and will not receive an implant.
No interventions assigned to this group
Interventions
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Sirolimus
SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently on hemodialysis for ≤12 months
* Successful creation of a single stage radiocephalic end to side fistula
Exclusion Criteria
* Planned start of peritoneal dialysis within 6 months of randomization
* Known hypersensitivity to the following: sirolimus, beef or bovine collagen
* Known to be HIV positive
* Prisoner, mentally incompetent, and/or current alcohol or drug abuser
65 Years
ALL
No
Sponsors
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Vascular Therapies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sriram Iyer, MD
Role: STUDY_DIRECTOR
Vascular Therapies, Inc.
Locations
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Veterans Affairs San Diego Health Center
San Diego, California, United States
Lundquist Institute for Biomedical Innovation
Torrance, California, United States
MedStar Cardiovascular Research Network at MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
American Access Care of Miami
Miami, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
University of Louisville
Louisville, Kentucky, United States
The Brigham and Women's Hospital
Boston, Massachusetts, United States
Mount Sinai Hospital
New York, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Surgical Specialists of Charlotte
Charlotte, North Carolina, United States
The Regional Medical Center/Dialysis Access Institute
Orangeburg, South Carolina, United States
James Eric Gardner, MD PC
Memphis, Tennessee, United States
Arteries & Veins
El Paso, Texas, United States
Houston Methodist
Houston, Texas, United States
Houston Methodist
Sugar Land, Texas, United States
Sentara Norfolk General Hospital/Sentara Health Research Center
Norfolk, Virginia, United States
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
St Helier Hospital
Carshalton, , United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Barts Health NHS Trust of Royal London Hospital
London, , United Kingdom
St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Countries
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Other Identifiers
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VT-305
Identifier Type: -
Identifier Source: org_study_id
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