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Post-market Registry to Assess the Clinical Performance and Safety of the Passeo-18 Lux in Infrainguinal Arteries

Ajou University School of Medicine · 2018
ClinicalTrials.gov · Datasets · License: Public Domain · 2018
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angioplastydiseasena
The purpose of his study is to collect short term and long term clinical evaluation data of the Passeo-18 Lux Paclitaxel releasing balloon catheter, subject to patients who visit hospital from arteriosclerosis in the infrainguinal arteries in actual clinical environment. Research institute for enrollment, and period; It is planned to enroll about 200 subjects in 9 domestic research institutes. It is expected to require about 12-18 months to enroll the subjects. Subject follow-up schedule; Perform follow-up by phone call or clinical assessment at 1, 6, 12, and 24 months of the postoperative time point
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