What is the LIFE-BTK PK Sub-Study? | Abbott
CARDIOVASCULAR
hamburger

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.


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

Scaffolding

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.

Pharmacokinetic (PK) profile

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 participate 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.

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

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.

CAUTION: Esprit™ BTK is an Investigational Device. Limited by Federal (USA) law for investigational use only.

Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Photos on file at Abbott.

Information contained herein for DISTRIBUTION to LIFE-BTK clinical trial sites ONLY.

Abbott
3200 Lakeside Dr., Santa Clara, CA 95054 USA. Tel: 1.800.227.9902

™ Indicates a trademark of the Abbott Group of Companies.

©2022 Abbott. All rights reserved. CL1015408

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.

False
accessibility
© 2021 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

accessibility

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.