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Prospective, multi-center, non-randomized clinical trial with follow-up investigations at 1, 6 and 12 months. To confirm safety and efficacy of Passeo-18 Lux DCB in new and non-stented re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in a Chinese patient population.
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A prospective, multi-centre, non-randomized clinical trial with follow-up investigations at 1, 6 and 12 months. Approximately 158 subjects will be enrolled at 15 Chinese study sites. To confirm the safety and efficacy of the Passeo-18 Lux DCB for the interventional treatment of new and non-stented re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in a Chinese patient population.
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158 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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