BIOFLOW-II trial will randomize approximately 440 patients with ORSIRO or XIENCE PRIME in a two-to-one manner at 19 European sites.
The ORSIRO hybrid drug-eluting stent (DES) features BIOTRONIK stent technology which combines passive and active components.
PROBIO passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue.
BIOlute active coating contains a highly biocompatible polymer that delivers a limus drug via a bioabsorbable matrix.
The primary endpoint to be assesed is in-stent late lumen loss at 9 months.
Secondary endpoints include clinically driven target lesion revascularization, target vessel revascularization and target lesion failure.
BIOTRONIK Vascular Intervention Sales and Marketing vice president Alain Aimonetti said the addition of the ORSIRO hybrid DES allows them to offer the product portfolio for vascular intervention and paves the way for the drug-eluting absorbable scaffold they are developing.
