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
ClinicalTrials.gov Identifier: NCT04225806
Principal Investigator: Mikel Sadek.


If you are registered as a volunteer, please login to the dashboard to send referrals.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.