Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion
brief summary
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB in patients with long femoropopliteal lesions who underwent percutaneous transluminal angioplasty using GENOSS PCB.
detailed description
This is a prospective, multicenter, single-arm, observational study designed to evaluate the long-term safety and effectiveness of the GENOSS paclitaxel-coated balloon (PCB) in patients with long femoropopliteal artery lesions treated with percutaneous transluminal angioplasty (PTA).
The study will enroll patients who undergo PTA using the GENOSS PCB at 4 hospitals. Approximately 300 patients are planned to be enrolled during the study period.
All enrolled patients will be followed for 12 months after the index procedure to assess the long-term safety and effectiveness of the GENOSS PCB. Additionally, the primary endpoints, major adverse event-free rate and primary patency, will be assessed during follow-up.
official title
Safety and Effectiveness of GENOSS PCB (Paclitaxel-coated Balloon) in Patients With Long Femoropopliteal Lesion: A Prospective, Multicenter, Observational Study (GENOSS-PCB Long)