LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS treatment-Below The Knee) Randomized Controlled Trial
Brief description of study
The purpose of this research study is to evaluate the safety and performance of the Study Device for the treatment of narrowed arteries in critical limb ischemia (CLI), and compare the results to the current standard of care using a balloon, also called percutaneous transluminal angioplasty (PTA), the only approved therapy for the disease within United States.
Clinical Study Identifier: s20-00294
ClinicalTrials.gov Identifier: NCT04227899
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