Clinical Research Directory

DRug-Eluting BallOOn Versus Primary Polymer-coated Paclitaxel Eluting STenting for Femoro-popliteal Lesions

Main objective of the study: To demonstrate that a primary DCB strategy is non-inferior in terms of primary patency to a primary SEDES strategy for above-the-knee femoro-popliteal lesions at 12 months. Primary endpoint: Freedom from loss of primary patency at 12 months: loss of primary patency will be defined as the need for target vessel revascularization and/or binary restenosis (defined as \>70% in diameter or peak systolic velocity \>2.4 m/sec at duplex examination). Secondary objectives: To demonstrate that a primary DCB strategy is non-inferior to a primary SEDES strategy in terms of: * Intra-operative technical success. * Safety at 1, 6, 12, 18 and 24 months. * Primary patency at 1, 6, 12, 18 and 24 months. * Assisted primary patency at 1, 6, 12, 18 and 24 months. * Secondary patency at 1, 6, 12, 18 and 24 months. * All target vessel revascularization at 1, 6, 12, 18 and 24 months. * Clinically-driven target vessel revascularization at 1, 6, 12, 18 and 24 months. * All TLR at 1, 6, 12, 18 and 24 months. * Clinically-driven TLR at 1, 6, 12, 18 and 24 months. * All target extremity revascularization at 1, 6, 12, 18 and 24 months. * Number of secondary interventions at 1, 6, 12, 18 and 24 months. * Binary restenosis at 1, 6, 12, 18 and 24 months. * Mean Rutherford category at 1, 6, 12, 18 and 24 months. * Mean ABI value at 1, 6, 12, 18 and 24 months. * Absolute claudication distance improvement at 1, 6, 12, 18 and 24 months. * Quality of life at 1, 6, 12, 18 and 24 months. * Cost at 1, 6, 12, 18 and 24 months.