The Access 2 Trial
Research type
Research Study
Full title
A Phase 3, Prospective, Randomized, Multicenter, Single-blind, Controlled Study evaluating Arteriovenous fistula outcomes with and without a Perivascular Sirolimus-eluting Collagen Implant
IRAS ID
1005084
Contact name
Rakesh Raghubanshi
Contact email
Sponsor organisation
Vascular Therapies, Inc.
Eudract number
2021-006718-36
Clinicaltrials.gov Identifier
Research summary
A fistula is made by joining together a vein and an artery in the arm, allowing blood from the artery to pass through the vein causing the vein to become stronger and larger. This makes the vein more suitable for the insertion of special needles that are required during hemodialysis.
Sometimes, in a fistula the vein narrows at the point where it is connected to the artery which slows down the blood flow from the artery to the vein and increases the chance that the fistula may not develop enough to be useful for hemodialysis. If this happens, the treatment options are another procedure to treat this narrowing, another surgery to create a new access or dialysis using a catheter.
The purpose of this study is to find out if the experimental drug, Sirolimus eluting Collagen Implant (also called the implant), is safe and effective in preventing or reducing the narrowing of the fistula where the implant is placed. The implant is an experimental drug because it has not been approved by the MHRA for this use. The implant contains a drug called sirolimus contained within a collagen membrane. Sirolimus has several actions:
• Sirolimus may be taken by patients who receive a kidney transplant, to prevent the body from rejecting the transplanted kidney
• Sirolimus is also used to coat stents. Stents are put in the blood vessels supplying blood to the heart during a procedure called angioplasty. Sirolimus works by reducing formation of tissue inside the stents.
In this study, once the implant is wrapped around the newly created fistula by the surgeon, sirolimus is released - it may reduce the narrowing in the vein, which in turn may allow the vein to enlarge (mature), and become usable for hemodialysis.
The Collagen Implant is absorbed after the drug is released.
This study will be randomised between no implant and the study implant and will be conducted at 3 UK sites. the study plans to enrol approx 120 subjects globally and subjects will be followed for approx 1 year.REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0483
Date of REC Opinion
16 Aug 2022
REC opinion
Further Information Favourable Opinion