The PIONEER-IV trial will take place over several years in 30 hospital centres across Europe and involve 2,540 patients.
The trial will use the newly patented Healing-Targeted Supreme Stent (HT Supreme™) from SINOMED. The novel drug-eluting stent is designed to encourage rapid healing of the treated blood vessel, thereby potentially reducing reliance on some long-term medications such as blood thinners.
The trial is sponsored by NUI Galway and centrally coordinated by the University’s CORRIB Research Centre for Advanced Imaging and Core Laboratory. University Hospital Galway (UHG) is the first European site to enrol patients.
Professor Faisal Sharif, Professor of Translational Cardiovascular Medicine and Innovation at NUI Galway and Consultant Interventional Cardiologist at UHG, is Principal Investigator on the trial in Ireland.
Professor Sharif said: “We are delighted to translate novel devices such as HT Supreme stents for Irish patients. The trial will also allow us to perform assessment on blood vessel narrowing with new and safer software that establishes the absolute necessity to treat that coronary artery stenosis. New devices and technologies, like offered in this trial, allow us to constantly improve the standard of care for our patients by making interventions safer with better clinical outcomes.”
Patients will be considered for the trial if they suffer any type of coronary heart disease, including acute heart attack, chronic complaints or blood vessel narrowing.
Eligible patients will undergo a refined physiological blood vessel selection process in order to determine which blood vessel has to be stented and which one could be treated with pharmacological therapy, without the use of a permanent implant. This strategy is the best guarantee of a safer and more cost-effective treatment.
NUI Galway’s CORRIB Core Lab is led by Professor Patrick W Serruys, Established Professor of Interventional Medicine and Innovation, and Professor William Wijns, Science Foundation Ireland Professor of Interventional Cardiology, both of whom are internationally renowned experts in interventional cardiology.
Co-chair of the PIONEER-IV trial, Professor Serruys said: “SINOMED has an international reputation for state-of-the-art stents with a healing-targeted mechanism that may help overcome the long-standing problem of traditional stent implantation, allowing for safer long-term results.”
Deputy chairman of the trial, Yoshi Onuma, Professor of Interventional Cardiology and medical director of CORRIB Research Centre, said: “The hope is that this trial will simplify the treatment for patients undergoing stent implantation of diseased blood vessels, and could offer benefits to patients when coupled with a shorter duration of blood-thinning medications.”
Professor Andreas Baumbach (London), Professor Javier Escaned (Madrid), Professor Faisal Sharif (Galway) and Professor Peter Smits (Rotterdam) will act as global Principle Investigators.
Professor Timothy O’Brien, Dean of NUI Galway’s College of Medicine, Nursing and Health Sciences, welcomed the trial. He said: “Leading this research from Galway is consistent with the University strategy to be a global leader in cardiovascular research and innovation and the presence of CÚRAM, the SFI Research Centre for Medical Devices, in the University. We are particularly happy to partner with SINOMED on this project which aligns with the University’s Global Galway project.”
Dr Jianhua Sun, PhD., chairman and chief executive officer of SINOMED, said: “We are honoured to be working with the prestigious thought leaders at NUI Galway in searching for a better and safer strategy for treating patients. We believe that our HT Supreme, coupled with an optimal treatment strategy can make a big impact in bringing a greater benefit to patients.”