Frequently Asked Questions About the LIFE-BTK PK SUB-STUDY

Can I still enroll in the LIFE-BTK study?

No. Patient enrollment is closed. However, patient enrollment is open for the LIFE-BTK PK SUB‑STUDY.

What treatment is being tested in the LIFE-BTK PK SUB-STUDY?

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'm enrolled in the LIFE-BTK PK SUB-STUDY?

If you're enrolled in the LIFE-BTK PK SUB‑STUDY, you will receive the Esprit™ BTK.

How long is participation in the LIFE-BTK PK SUB-STUDY?

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

How many participants are being enrolled in the LIFE-BTK PK SUB-STUDY?

Once fully enrolled, the LIFE-BTK PK SUB-STUDY will evaluate 7 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 PK SUB‑STUDY. You can also ask your doctor or email for more information about your eligibility.