LIFE-BTK FAQ | Abbott
CARDIOVASCULAR
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Frequently Asked Questions about the LIFE-BTK Study

What treatment is being tested?

This is a study to test the Esprit™ BTK resorbable scaffold, a new device for the treatment of CLI. The device is implanted in the artery immediately after a balloon angioplasty, providing support and preventing the vessel from reclosing. The scaffold releases a drug into the artery over a few months that promotes healing and keeps the artery open. The device is made of a material that dissolves over time and will be gone from your body in about 3 years.
 

Which treatment will I receive if I participate in the study?

LIFE-BTK is a randomized, controlled study. This means that half of the patients will be randomly assigned to the “treatment arm” (Esprit™ BTK resorbable scaffold following balloon angioplasty) and half will be randomly assigned to the “control arm” (balloon angioplasty alone).
 

How long is participation in the study?

Patients in this study will have 10 study visits over 5 years.
 

How many participants are being enrolled?

Once fully enrolled, the LIFE-BTK study will evaluate the Esprit™ BTK resorbable scaffold compared to balloon angioplasty alone in 225 patients from around the world.
 

What are the benefits of participating in a clinical study?

Clinical studies are very important to advancing medicine and can help others lead healthier lives. Some people join a study because the treatments they have tried for their health problem did not work or because there is no treatment available. By being part of a clinical trial, participants may gain access to new treatments before they are widely available.
 

How do I know if I am eligible to participate in the study?

There are multiple criteria that patients must meet to qualify for the LIFE-BTK study. Visit the Do I Qualify for the LIFE-BTK Study? page to learn more. You can also ask your doctor or email Life_BTK@abbott.com for more information about your eligibility.

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.

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

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