Eurocor announces the completion of the Freeway Stent Study

Bonn, Germany.,  Eurocor, an international specialist in medical DEB - technology, services and solutions, today announced the completion of the Freeway Stent Study. 
The Freeway Stent Study was lead-managed by Prof. Dr. Josef Tacke, Klinikum Passau, Germany. The multicenter, open, prospective randomized study investigated the prevention of restenosis in the treatment of Superficial Femoral Artery (SFA) or Popliteal artery (PI-segment) lesions in the legs. The study examined whether implantation of a Nitinol stent followed by post-dilatation with a drug-eluting balloon (DEB) FREEWAYTM is advantageous to Nitinol stenting and post-dilatation by a plain old balloon angioplasty (POBA). The study was conducted in 13 sites in Germany and Austria. 204 patients suffering from de novo lesions that needed to be stented were enrolled and randomized in a 1:1 ratio. Patients have been followed at 6 and 12 months. 

The 6 Months results 

Final 6 months results of the Freeway Stent Study have been presented at CIRSE (Cardiovascular and Interventional Radiological Society of Europe) congress 2016, Barcelona, Spain. The results show a significant better primary patency for the DEB arm compared to the POBA arm (91.4 % vs. 74.4 %, respectively; p = 0.003) at follow-up, analyzed by an independent and blinded corelab. The results also show a very low target lesion revascularization (TLR) rate of only 4.1 % after treatment with FREEWAYTM DEB, whereas the POBA group shows a TLR rate of 9.0 %. These findings go along with a significant improvement in Rutherford classification (94.4% vs. 84.3%, respectively; p = 0.027) and a significant improvement in Ankle-Brachial-Index (ABI Index) at follow-up. 

Prof. Dr. Josef Tacke commented: “In-stent restenosis is a serious problem in the SFA  and PI-segment. The 6 months results of our study have shown, that Drug-eluting  balloons are a good and desirable option to prevent restenosis in patients that need to  be stented. After the very positive results at 6 months we are now looking forward to the  12 months results of the study.”