Visit ClinicalTrials.gov
To learn more about the TECTONIC CAD IVL IDE Study.
Frequently Asked Questions About the TECTONIC CAD IVL IDE Study
What treatment is being tested?
The treatment being investigated is called the SonicForce™ 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?
335 patients have been enrolled in the TECTONIC CAD IVL IDE Study in the United States.
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.
CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only. Outside the U.S., the device is subject to local regulatory requirements and is not commercially available.
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