Completed Heart, Stroke & Blood Digestion, Kidneys & Other Organs

A clinical study to assess the safety and efficacy of POSS-PCU small diameter grafts as conduits in arteriovenous (AV) access and coronary artery bypass graft (CABG) surgery.

Funder Wellcome Charity-funded
Recipient organisation University College London
Funding £1.5M
Period Feb 2014 — May 2018

In plain English

AI plain-English summary

Every year, thousands of kidney dialysis patients and heart bypass recipients need a synthetic blood vessel—but the small-diameter plastic tubes currently used fail at alarming rates, clotting or stiffening until they block. This clinical trial will test a new polymer graft, made from a material called POSS-PCU, in two groups of patients: those needing a connection for dialysis access and those undergoing coronary artery bypass surgery. The problem is that existing synthetic grafts—made from ePTFE, Dacron, or polyurethane—are too rigid and prone to triggering harmful tissue growth, leading to failure within months or a few years. The new material is designed to match the flexibility of natural arteries and resist clot formation. In large animal studies, it has shown unusually good long-term patency. If the trial confirms safety and effectiveness in humans, the results will feed into a regulatory dossier for CE marking. Success would give surgeons a reliable, off-the-shelf small-diameter graft, reducing the need for repeated surgeries and improving outcomes for the tens of thousands of patients who depend on vascular access or bypass grafts each year.

View original technical description
The requirement of a prosthetic graft with a non-thrombogenic surface with sufficient mechanical strength and compliance to the native vessels, resistance to intimal hyperplasia and compatibility with the host tissues remains a major unmet clinical need. Small diameter grafts (5 mm) made from polyhedral oligomeric silsesquioxane (POSS) - poly (carbonate-urea) urethane (PCU) has demonstrated unparalleled patency, compliance and biocompatibility in a challenging large animal model (sheep). The key goals of the proposed research are evaluating their performance and confirming safety in humans by conducting a clinical trial in renal access and coronary artery bypass grafting (CABG) as data from the renal access study will be fed into the Design Dossier for CE marking the CABG grafts. Prosthetic grafts from ePTFE, Dacron and polyurethane have been used in renalaccess, but they are known to fail due to graft thrombogenicity, compliance mismatch between the graft and native vessels and intimal hyperplasia formation. Similarly, there is a unmet clinical need for a readily available, functional, small-diameter vascular graft in CABG. Studies have been conducted to develop novel small-calibre prostheses but synthetic materials have not been successful so far because of their poor long-term patency rates.The proposed research aims to address this important clinical issue and a budget of 1.6M would enable us to cover both the renal access and CABG trials to improve patient outcomes in both fields.

View the original record at the funder ↗

Researchers

SEIFALIAN (EPMC Awardee)

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Original classification

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