SINOMED has collaborated with the National University of Ireland (NUI) Galway to carry out a clinical trial of a new evaluation technique for stenting.
The PIONEER IV trial will use the patented HT Supreme Healing-Targeted Drug-Eluting Stent (DES), which can potentially be used to treat heart disease patients.
The HT Supreme is designed to expedite the wound-healing process as well as help restore the natural protective function of their vessels.
This approach is expected to lower dependence on long-term drugs such as blood thinners.
A prospective, single-blind, randomised, controlled and multi-centre trial, PIONEER IV will enrol 2,540 adult subjects with any kind of coronary heart disease, including acute heart attack, chronic complaints or vessel narrowing.
To be enrolled at 30 hospitals in Europe, the subjects will undergo a non-invasive physiological vessel selection process to identify the vessel that needs stenting.
All participants will be implanted with the HT Supreme DES and receive dual-antiplatelet treatment for a month following stenting.
The trial will analyse the clinical outcomes of angiography-derived physiology guidance as against local routine diagnostic procedure (LRDP) and standard care in subjects who undergo percutaneous coronary intervention with unrestrictive HT Supreme usage.
SINOMED chairman and CEO Dr Jianhua Sun 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 benefit to patients.”
Sponsored by NUI Galway, the trial will be centrally managed by the university’s CORRIB Research Centre for Advanced Imaging and Core Laboratory.
NUI Galway College of Medicine, Nursing and Health Sciences dean Professor Timothy O’Brien said: “Leading this research from Galway is consistent with the university strategy to be a global leader in cardiovascular research and innovation and complements the presence in the University of CURAM, the SFI Research Centre for Medical Devices.”
University Hospital Galway is the first centre to recruit PIONEER IV trial participants in Europe.