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The use of paclitaxel coated DCB during percutaneous transluminal angioplasty (PTA) treatment of the femoropopliteal lesions in PAD patients might result in a significant reduced restenosis rate. Thus, the FREERIDE study investigates the inhibition of restenosis by the FREEWAY DCB versus plain balloon (POBA) in the treatment of occluded or stenotic lesions in the superficial femoral artery (SFA) and popliteal arteries (PI segment).
280 patients will be randomized either to FREEWAY DCB or to POBA in 23 centers worldwide. The primary endpoint is clinically driven target lesion revascularization rate (TLR) at 6 months. Secondary endpoints include late lumen loss and patency rate at 6 months, TLR at 12 and 24 months follow up (FU), improvement in Rutherford classification and Ankle-Brachial index (ABI) and MAE.
Until today over 100 patients have been enrolled, over 80 of them completed the 6 month FU. At 6 months FU positive trends are observed for the TLR rate (7.1 % vs. 16.7 % after POBA) and MAE (7.1 % vs 23.4 % after POBA). Furthermore there are positive trends in the patency rate and in the improvement of Rutherford classification after FREEWAY PTA vs. POBA.
The continuously updated interim results indicate that FREEWAY DCB might provide an advantage for angioplasty in SFA and PI-segment lesions. DCB might overcome the existing limitations in the treatment of peripheral disease.