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

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

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).

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; ESRD; End Stage Kidney Disease; Arteriovenous Fistula; Vascular Access Complication; Chronic Kidney Failure; Complication of Hemodialysis; Complication of Renal Dialysis
• Intervention / Treatment: Drug: Sirolimus; Procedure: AV Fistula Surgery; Device: Sirolimus-eluting Collagen Implant (SeCI)

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.

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Nephrology Consultants, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • AKDHC Medical Research Service
  • California
    • Escondido, California, United States, 92025
      • San Diego Institute of Medical Research
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Northeast Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; AV fistula surgery Single administration of sirolimus-eluting Collagen implant	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
Other: Control Group; AV fistula surgery	Procedure: AV Fistula Surgery; AV Fistula Surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vascular Therapies, Inc.
• Investigators: Study Director: Sriram Iyer, MD, Vascular Therapies, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (Estimated): July 31, 2015

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Chronic Kidney Disease; ESRD; Chronic Renal Failure; Dialysis; Hemodialysis; Vascular Access; AVF; Nephrology; Vascular Surgery; Arteriovenous Fistula; Chronic Kidney Failure; End Stage Kidney Disease; AV Fistula; Dialysis Access
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Arteriovenous Fistula; Organic Chemicals; Macrolides; Lactones; Sirolimus
• Other Study ID Numbers: VT-304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No