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Eurocor’s DEBIFU Registry successfully enrolled first patients

Date: 2012/09/24

Eurocor GmbH is pleased to announce the successful start of the DEBIFU registry. This prospective multicenter national registry is designed to assess the safety and efficacy of the drug-eluting balloon DIOR® in the treatment of bifurcation lesions of all Medina classes. The widely used Medina classification provides a simple way to characterize the three sections of bifurcation lesions by using a binary system. A stenosis greater than 50% is coded as “1” and a stenosis less than 50% as “0”. Accordingly a 1,1,1, bifurcation lesion shows a greater than 50% stenosis in the proximal main branch, the distal main branch and the side branch.

Under the direction of Principal Investigator (PI) Dr. Hubertus von Korn, Hospital Hetzelstift, Neustadt an der Weinstraße (Germany), this registry will enroll 100 patients at four German sites.

Primary endpoints of the registry are clinically driven or ischemia guided target lesion revascularization (TLR) and Major Adverse Cardiac Events (MACE) at 9 months follow up. Secondary endpoints include the frequency of technical aspects such as the incidences of additional stenting in the side or main branch or final kissing procedures. All four participating study sites have recently been initiated and started enrollment.

Dr. Pogge von Strandman, Vice President Clinical Department Eurocor GmbH, commented: “We are pleased to see an immediate response to the Registry announcement. So far we have 19 patients registered at the four study sites. With the special efforts of Dr. Hubertus von Korn and all other investigators involved, we are looking forward to the complete enrollment by the end of 2012.”

Press Release: Eurocor’s DEBIFU Registry successfully enrolled first patients