Somahlution has announced that Golden Jubilee National Hospital and Victoria Blackpool Hospital in the UK have initiated patient enrolment in the DuraGraft European registry clinical trial.
The registry will evaluate the benefits of treatment with DuraGraft; a one-time intraoperative treatment designed to prevent vascular graft disease and graft failure and reduce the clinical complications associated with graft failure in patients treated with coronary artery bypass grafting (CABG). According to a press release, DuraGraft is a pH and ionically-balanced solution containing salts, antioxidants and other important components to protect against ischaemia reperfusion injury in which the graft may be safely preserved and stored prior to implantation.
Patients undergoing CABG-only or CABG-plus valve surgery will be consented to participate in the DuraGraft European registry. For these patients, baseline clinical and angiographic characteristics as well as certain procedural and post-op clinical events will be recorded. Clinical outcomes will be assessed post-CABG surgery through hospitalization at 30 days and annually up to five years.
Nawwar Al-Attar (Golden Jubilee National Hospital, Glasgow, UK) comments: “In many cases, vascular conduits can be at risk during CABG surgery. A growing body of evidence shows that the DuraGraft solution may help preserve and store vascular grafts in the operating room prior to implantation and potentially prevent graft rejection. We are looking forward to participating in this important research with the University of Glasgow and to the prospect of bringing this innovative technology to appropriate CABG patients in the years ahead.”
Maximilian Y Emmert (University of Zurich, Zurich, Switzerland), the registry lead principal investigator, says: “As more leading hospitals and surgeons across Europe join this important registry, we believe the collected data will provide further supporting evidence reinforcing the importance of appropriate graft treatment during surgery and the role of DuraGraft in improving outcomes.”
DuraGraft is the first commercial product based on proprietary technology platform. DuraGraft is CE Marked in Europe and available in other global markets for CABG and peripheral bypass indications, and is not yet commercially available in the USA.