The **TECTONIC CAD IVL IDE Study** is a research project to test a special heart treatment device called the **Abbott Coronary IVL System**. This device helps open up blocked heart arteries that have hard calcium deposits. The study will include 335 people in the US and will take place at up to 55 different locations. The goal is to make sure the device is safe and works well before it is sold in the US.
Participants must be 18 or older, agree to the study rules, and have certain heart conditions. Some people cannot join, like those who are pregnant, have severe heart issues, or have other medical conditions that might interfere with the study.
- **Length & Visits**: The study involves several visits over time, but the exact number is not specified.
- **Risks**: There are potential risks, like any medical procedure, and it's important to discuss them with your doctor.
- **Eligibility**: Make sure you meet all the criteria before considering participation.
This study is important to help doctors find better ways to treat heart diseases.
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