University partners with Sahajanand Medical Technologies to test new device for interventional cardiology
NUI Galway and leading medical device company Sahajanand Medical Technologies (SMT) have teamed up to conduct a clinical trial of a new generation of stents on patients suffering the most severe form of coronary artery disease.
The Multivessel Talent trial is running at more than 50 locations in eight countries and involves 1550 patients with three-vessel coronary artery disease, which affects about one fifth of all people with heart disease.
The trial is sponsored by NUI Galway and will be centrally coordinated by the University’s Corrib Research Centre for Advanced Imaging and Core Laboratory.
University Hospital Galway (UHG) is the first European site that has start enrolling patients in the trial. So far four patients have been successfully treated. The trial will run over several years and the research team will periodically assess participating patients.
The principal investigator on the trial in Ireland, Professor Faisal Sharif, Professor of Translational Cardiovascular Medicine and Innovation at NUI Galway and Consultant Interventional Cardiologist at UHG, said: “As well as it being the most severe form of coronary artery disease, three vessel disease is increasingly an issue for younger people.
“Coronary heart disease means that the blood supply to heart muscle is reduced or blocked due to build-up of fatty tissue, which is known as atherosclerosis. There are many risk factors for this condition but unhealthy lifestyle plays a critical role in its progression.
“Coronary artery stenting has made great progress in terms of ease of use, clinical outcomes and technological advances. Three vessel coronary artery disease represents one of the most severe forms of the disease and this clinical trial is important as it will assess a new generation of coronary stents for these high-risk patients.”
Professor Sharif added: “The key aim of the study is to assess future treatments of coronary arteries, long-term patient survival and quality of life.”
Professor Timothy O’Brien, Dean of the College of Medicine, Nursing and Health Sciences at NUI Galway, said: “The commencement of this Multivessel Talent trial, sponsored and led by NUI Galway in partnership with Sahajanand Medical Technologies, will enhance engagement with the regional, national and international medtech industry.
“It highlights the central role NUI Galway plays in the medtech sector, both in Ireland and internationally, and it marks a momentous recognition of the excellence of research and development and clinical trial activities here in the University. It also aligns closely with the University’s and national strategic priorities in medtech.”
The Multivessel Talent trial is a randomized, multi-centre study implementing best practice interventional cardiology to compare clinical outcomes between two CE-mark approved contemporary coronary devices – SUPRAFLEX Cruz and SYNERGY drug eluting stents.
The trial will take place in 50 centres across Europe. All patients will be treated for three vessel disease. This severe form of coronary artery disease is usually seen in patients with diabetes mellitus, high blood pressure, a strong family history of heart disease and smoking.
Eligible patients from the west of Ireland who have not previously had by-pass surgery will be offered the opportunity to participate in the trial.
The trial is co-chaired by CORRIB Research Center for Advanced Imaging and Core Laboratory Professor Patrick W Serruys, Established Professor of Interventional Medicine and Innovation at NUI Galway, and Professor William Wijns, Science Foundation Ireland Professor of Interventional Cardiology at NUI Galway, both of whom are internationally renowned experts in interventional cardiology and cardiovascular disease. Prof Yoshi Onuma, Professor of Interventional Cardiology and medical director of CORRIB Research Centre, is deputy chairman of the trial. Prof Helge Moellmann (Dortmund), Prof Manel Sabate (Barcelona) and Prof Azfar Zaman (Newcastle) will act as global Principle Investigators.
Professor Serruys said: “The Multivessel Talent trial is a pan-European trial, applying best practice principles endorsed by the European Society of Cardiology. In addition to assessing the contemporary stents, the trial will also investigate novel methods to assess coronary artery stenosis severity.
“SMT is a forefront manufacturer of stents in India, with an international reputation for state-of-the-art stents with ultra-thin struts. This company is partnering with NUI Galway and the CORRIB Research Centre at NUI Galway which will coordinate this study.”
Professor Onuma added: “All angiographies will be centrally analysed with Quantitative Flow Reserve (QFR) using MEDIS software in the independent CORRIB Core Lab at NUI Galway that will provide the investigators with clear identification of flow-limiting narrowing.
“The hope is that this trial will simplify the treatment for patients with three vessel disease undergoing coronary angioplasty, a non-surgical procedure used to treat narrowing of the coronary arteries of the heart.”
NUI Galway has partnered extensively with the medical device industry in both research and development and in clinical trial activities through the HRB Clinical Research Facility, Galway.