Investigation of Femoropopliteal In Situ Valve Formation with the InterVene System (INFINITE-US)

Brief description of study

The purpose of this study is to look at how safe and effective the BlueLeaf System (BLS) works in creating valve-like structures to help keep blood circulating like it’s supposed to and to keep it from pooling in your feet. This study is called an “early feasibility study”. Early feasibility studies are a type of research study that typically evaluate new devices or new uses of approved devices. These studies enroll a small number of patients and provide initial information on the basic safety and performance of the study device. There is often only limited data and experience treating this condition with the study device.

Clinical Study Identifier: s18-00386 Identifier: NCT04225806

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