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Completed

NCT Number: NCT02513303

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

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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Key information

Conditions

Complication of Renal Dialysis Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Chronic Kidney Failure Complication of Hemodialysis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes ESRD End Stage Kidney Disease End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Access Complication Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nephrology Consultants, LLC, Huntsville, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sirolimus

Drug

A single dose of sirolimus delivered locally

Other names: Rapamycin

AV Fistula Surgery

Procedure

AV Fistula Surgery

Sirolimus-eluting Collagen Implant (SeCI)

Device

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

Primary outcomes

  1. Fistula Suitability for Dialysis at 6 Months (FSD6)

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Vascular Therapies, Inc.

Industry

Registry information

Official study title

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

Acronym: ACCESS

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jul 31, 2015
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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