First in Man Safety & Effectiveness evaluation,ArterioSorb™ BRS System

• Research type

  Research Study

• Full title

  A prospective, multicentre, open labelled, single arm, first in man interventional investigation to evaluate the safety and effectiveness of the ArterioSorb™ bioresorbable stent for the treatment of patients with coronary artery disease.

• IRAS ID

  279496

• Contact name

  Jonathan Hill

• Contact email

  J.Hill@rbht.nhs.uk

• Sponsor organisation

  Arterius Limited

• Duration of Study in the UK

  10 years, 0 months, 0 days

• Research summary

  Research Summary

  Coronary artery disease is the most common of the cardiovascular diseases (CVD) and is the leading cause of death worldwide. Although the mortality for this condition has gradually declined over recent years in developed countries, one in 8 men and one in 13 women in the UK still die of coronary artery disease. Healthcare costs relating to CVD are estimated to be £9 billion each year in the UK.

  ArterioSorb™ has been developed by Arterius: a Leeds based company founded in 2009. ArterioSorb™ is a polymer-based bioresorbable stent that is intended to match the ease of delivery of a drug eluting stent (DES). It is anticipated that the product will provide equivalent mechanical performance to the best-in-class DES products.
  This first in man trial will be testing the stent delivery system. This study aims to evaluate the safety and effectiveness of the ArterioSorb™ bioresorbable stent for use on patients with coronary artery disease

  Summary of Results

  This trial entitled “A prospective, multicentre, open labelled, single arm, first in man interventional investigation to evaluate the safety and effectiveness of the ArteriosorbTM bioresorbable stent for the treatment of patients with coronary artery disease”, was Sponsored by Arterius Limited, a small-medium enterprise based in Leeds specialising in the development of innovative medical devices. Funding for the trial was provided by Innovate UK, a UK agency providing money and support to organisations to make new products and services.
  Four NHS organisations in England were involved in the research; Royal Brompton Hospital, University Hospitals Bristol, The Royal Bournemouth Hospital and the Essex Cardiothoracic Centre. The first site was initiated to start recruitment on 16 November 2021.

  Coronary artery disease is the most common of the cardiovascular diseases and is a major cause of death and disability in developed countries.
  Over the period of 2012/2013, the NHS spent more than £6.8 billion treating cardiovascular diseases in various ways. The greatest cost was on emergency admissions within secondary care, while primary care saw the majority of costs come from prescribing.
  The ArterioSorb™ stent, developed by Arterius, is a bioresorbable device intended to match the ease of delivery of a drug eluting stent.

  The ArterioSorb™ first in man trial was to test the stent delivery system, using a medicinal product commonly included as part of other available stent products. The trial aimed to evaluate the safety and effectiveness of the ArterioSorb™ bioresorbable stent in patients with stable coronary artery disease.

  Over 6 months of the trial being open at the sites, five patients were consented into the trial and these all failed the screening process. The screen fails were due to various reasons :- complex cases, artery length/width not meeting the criteria and patient withdrew consent. No patients received the ArterioSorb™ stent and patients initially consented into the trial received standard of care stents. No adverse events, serious adverse events or reactions were noted in any of the patients who consented and then screen failed.

  The trial steering committee met to discuss how improvements could be made to recruitment and numerous suggestions were made. Arterius considered additional stent sizes and liaised with the regulatory authorities, who confirmed that a new trial would be required if additional stent sizes were to be included. Arterius made the difficult decision to prematurely end the trial. No study results are available as no patients received the ArterioSorb™ stent.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  21/LO/0118

• Date of REC Opinion

  29 Mar 2021

• REC opinion

  Further Information Favourable Opinion