The multicentre, open, prospective randomised trial investigates the prevention of restenosis by stenting with a nitinol stent followed by a drug-eluting balloon (DEB) (Freeway) vs. stenting with a nitinol stent with plain old balloon angioplasty (POBA) post dilatation in the treatment of superficial femoral artery or popliteal artery (PI-segment) lesions in the legs.
“In-stent restenosis is a serious problem in the superficial femoral artery 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,” said Josef Tacke, Klinikum Passau, Germany, study’s lead investigator.
The randomised, study is being conducted in 15 European sites to investigate the rate of clinically driven target lesion revascularisation. Two hundred patients suffering from de novo lesions that need to be stented will be enrolled and are randomised in a 1:1 ratio. Both groups will be treated with nitinol stent implantation first following randomisation 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 six-month follow-up is now available for 23 patients. Thirteen of them have been treated with a nitinol stent and a DEB. The trend shows a very low target lesion revascularisation rate of 7.7%, whereas the second group of 10 patients that have been treated with the nitinol stent and POBA are showing a target lesion revascularisation 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 six months. The analysis will be performed by an independent core lab.
“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 Rembert Pogge von Strandmann, director Clinical Department, Eurocor.
