What is the LIFE-BTK
PK SUB-STUDY?

Patient enrollment is complete for the LIFE-BTK PK Sub-Study. A special thanks to the investigators, research coordinators and enrolled patients for making this trial possible.

What is the LIFE-BTK PK Sub-Study?

A Study to Understand How the Drug from the Esprit™ BTK Scaffold is Processed in the Body

A sub-study to the LIFE-BTK main study in patients with critical limb ischemia (CLI).

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.

 

Animation of everolimus drug being released from the scaffold after implantation in the leg.

What is a PK 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.
 

Animation of pharmacokinetics, showing drug concentration over time in the blood after a drug enters the body.

Tell me more about the drug being studied

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.

  • Patients who are enrolled in the LIFE-BTK PK SUB-STUDY will have their blood drawn at multiple time points to measure the amount of drug that is present in their body
  • Most of the blood draws will take place within the first week after implantation to measure when the maximum dose of drug is reached and how quickly it is removed from the body.
  • Patient enrollment is now complete in the LIFE-BTK PK Sub-Study.

Participation in this study will help bring new treatment options to other patients like you.

Learn More About Clinical Studies

Reference

  1. Rizik DG, Cannon L, Stone GW, et al. Systemic pharmacokinetics of everolimus eluted from the absorb bioresorbable vascular scaffold: An ABSORB III substudy. J Am Coll Cardiol. 2015;66 (21):2467-2469.