Complication of Renal DialysisPhase 3ACCESSNCT02513303
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
A Phase 3 study testing Sirolimus, AV Fistula Surgery and Sirolimus-eluting Collagen Implant (SeCI) in people with Complication of Renal Dialysis and End Stage Renal Disease, run by Vascular Therapies, Inc. at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease
- What is being tested?
- Sirolimus, AV Fistula Surgery and Sirolimus-eluting Collagen Implant (SeCI)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2015to Jun 2021
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
San Diego Institute of Medical Research
Escondido, California, 92025
Nephrology Consultants, LLC
Huntsville, Alabama, 35805
AKDHC Medical Research Service
Phoenix, Arizona, 85012
About this study
Official title: 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).
Read the 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.
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD, Chronic Kidney Failure, Complication of Hemodialysis
- Being tested
- Sirolimus, AV Fistula Surgery, Sirolimus-eluting Collagen Implant (SeCI)
- 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
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called Rapamycin
A single dose of sirolimus delivered locally
AV Fistula SurgeryProcedure or surgery
AV Fistula Surgery
Sirolimus-eluting Collagen Implant (SeCI)Device
Also called Rapamycin
SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | AV fistula surgery Single administration of sirolimus-eluting Collagen implant Receives: Drug: Sirolimus; Procedure: AV Fistula Surgery; Device: Sirolimus-eluting Collagen Implant (SeCI) |
| Control Group | Other | AV fistula surgery Receives: Procedure: AV Fistula Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Complication of Renal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sriram Iyer, MD, Study director, Vascular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513303
- Sponsor's protocol ID
- VT-304
- Acronym
- ACCESS
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2015
- Last updated
- 9 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No