US-based biotechnology firm Somahlution has begun enrollment in Spain for the DuraGraft CABG European Registry trial of its product DuraGraft, to improve clinical outcomes post coronary artery bypass grafting (CABG) surgery.
DuraGraft is a vascular graft treatment equipped with the GALA technology platform licensed by the firm from the US Department of Veterans Affairs.
The product is designed to improve long-term clinical outcomes after the CABG surgery, by decreasing the incidence of complications of graft failure.
The registry is a prospective, multi-centre, observational study to evaluate and document the clinical use of DuraGraft and associated outcomes.
Somahlution vice president and chief medical officer Tracy Goeken said: "While our 2,400 patient US retrospective study has already provided convincing real world evidence supporting the clinical benefit of DuraGraft, we anticipate our European registry will complement and support these findings.”
The Spanish registry has enroled patients from Hospital De Cruces Barakaldo, Bilbao, Hospital Ramon y Cajal and Hospital Gregorio Marañon, Madrid and Complejo Hospitalario Universitario de Santiago de Compostela.
The study will be conducted in patients undergoing CABG or CABG plus valve surgery and the clinical outcomes post CABG through hospitalisation, at 30 days, and annually up to five years will be evaluated.
Outcomes such as baseline clinical and angiographic characteristics, certain procedural and post-op clinical events will be considered.
DuraGraft has received CE Mark in Europe and is available in other global markets for CABG and peripheral bypass indications, while it is yet to be commercially availabile in the US.