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TECTONIC CAD IVL IDE Study

TECTONIC CAD IVL IDE Study
FAQ

Frequently Asked Questions About the TECTONIC CAD IVL IDE Study

What treatment is being tested?

The treatment being tested is called the Coronary IVL System. It's designed to treat coronary arteries that are severely blocked by hard calcium buildup. Before placing a stent, the system uses a balloon to widen the narrowed sections of the blood vessels in the heart. The Abbott TECTONIC CAD Intravascular Lithotripsy (IVL) IDE study will check if this new system is safe and effective.
 

How long is participation in the study?

Participation in the study lasts for 2 years. During this time, you'll have 4 follow-up visits. These visits can be done in person or over the phone.
 

How many participants are being enrolled in the study/sub-study?

There will be about 335 patients participating in the TECTONIC CAD IVL IDE Study in the United States.
 

How do I enroll in the study?

If you have been diagnosed with coronary artery disease or are scheduled to undergo a procedure called percutaneous coronary intervention, you may be eligible to join the TECTONIC CAD IVL IDE Study. Talk to your doctor to see if this study is right for you.
 

What are the benefits of participating in a clinical study?

Clinical studies are crucial for advancing medicine and can help others live 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. There is no guarantee that you will receive any benefit from participating in the study. However, the information gathered in this study may help improve the understanding of treatment options for patients with coronary artery disease.
 

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

To join the TECTONIC CAD IVL IDE Study, you need to meet a few requirements:

  • You must be at least 18 years old.
  • You need to be able to give your permission to participate.
  • You should be a good candidate for a procedure to treat blocked or narrowed heart arteries.

You can also talk to your doctor to see if you qualify for this study and learn about treatment options that are available to you.

Visit ClinicalTrials.gov

To learn more about the Coronary IVL IDE Study.

Contact us

If you have questions, please email us

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