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Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries

C. R. Bard · 2015
ClinicalTrials.gov · Datasets · License: Public Domain · 2015
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The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.
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