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Eurocor announces first insights of the Freeway Stent Study at LINC Congress

Date: 2012/02/02

Freeway™ drug-eluting balloon for treatment of de novo lesions in the SFA or popliteal arteries

Eurocor GmbH, an Opto Circuits group company, unveiled the first insights of the ongoing Freeway Stent Study during the Eurocor Symposium at Leipzig Interventional Course (LINC), Germany. The study is lead-managed by Prof. Dr. Josef Tacke, Klinikum Passau, Germany. The multicenter, open, prospective randomized trial investigates the prevention of restenosis by stenting with a Nitinol Stent followed by a drug-eluting balloon (DEB) Freeway™ versus stenting with a Nitinol Stent with plain old balloon angioplasty (POBA) post dilatation in the treatment of Superficial Femoral Artery (SFA) or Popliteal artery (PI-segment) lesions in the legs.

The randomized, prospective clinical study is being conducted in 15 European sites to investigate the rate of clinically driven target lesion revascularization (TLR). 200 patients suffering from de novo lesions that need to be stented will be enrolled and are randomized in a 1:1 ratio. Both groups will be treated with Nitinol stent implantation first following randomization in a 1:1 ratio to postdilatation with a drug-eluting balloon (Freeway DEB) or a plain old balloon (POBA). Currently 82 patients have been enrolled, whereof a 6 month follow-up is now available for 23 patients. 13 of them have been treated with a Nitinol stent and a DEB. The trend shows a very low target lesion revascularization (TLR) rate of 7.7%, whereas the second group of 10 patients that have been treated with the Nitinol stent and POBA are showing a TLR rate of 20%.

During the 6th and 12th month, the patient will undergo a Duplex follow-up as well as an angiographic follow-up in a subgroup at 6 month. The analysis will be performed by an independent core lab.

Prof. Dr. Josef Tacke commented: “In-stent restenosis is a serious problem in the SFA and PI-segment. Drug-eluting balloons might be an option to prevent restenosis at an early stage for patients that need to be stented. The first insights are very promising and we are looking forward to the final results of the study.”

“The trend so far shows a good and safe performance of our drug-eluting balloon Freeway. We trust that our DEB technology platform used in the Freeway Stent Study will offer better treatment options and significant therapeutic advantages for the patients,” said Dr. Rembert Pogge von Strandmann, Director Clinical Department, Eurocor.

PR first insights of the Freeway Stent Study

Eurocor präsentiert erste Trends der Freeway Stent Studie