For more information about the LIFE-BTK study or LIFE-BTK PK SUB-STUDY.
This sub-study is to better understand how the drug everolimus that is on the Esprit™ BTK scaffold is processed in the body. Once the scaffold is implanted in a blood vessel, the drug promotes healing and helps keep the blood vessel open. Patient enrollment is complete for the LIFE-BTK PK Sub-Study.
The study of how a drug is processed in your body is called pharmacokinetics (PK). The purpose of this type of study is to learn how a drug moves into the body, through it, and out of the body. It describes how much of the drug the body absorbs and the way the body removes the drug over time.
Everolimus, the drug on Esprit™ BTK, is found on other devices, such as heart stents that are used regularly in patients with heart disease. This drug has been tested extensively and has been found to be safe in humans.1
The amount of everolimus on Esprit™ BTK is being studied to understand how the drug is processed by the body when several of the Esprit™ BTK scaffolds are placed in the leg. Similar to its use with heart stents, only a small amount of drug is released from the scaffold. It is expected that the amount will become less and less over time and will no longer be present in the body within 30 to 60 days after a patient receives the device.