Cardionovum has announced the enrolment of the first patient in the MAGNIFICENT trial—a multicentre, randomised, controlled clinical trial comparing the efficacy of the Legflow drug-coated balloon (DCB) with conventional percutaneous transluminal angioplasty (PTA) in de novo or recurrent lesions in the superficial femoral artery (SFA) or popliteal segment.
The trial will enrol 130 patients across multiple sites throughout Europe. The primary endpoint is the binary restenosis rate at 12 months and is determined by duplex ultrasonography.
Principal Investigator, P Goverde from the ZNA Stuivenberg hospital in Antwerp, Belgium, commented, “We are very enthusiastic about starting the MAGNIFICENT trial, as the Legflow DCB has the potential to become the gold standard to replace conventional treatment in this indication. We congratulate Inge Fourneau at the UZ Leuven hospital in Belgium for enrolling the first patient.”