TECTONIC CAD IVL IDE Study

Registration Information

If you choose to participate

If you decide to join the TECTONIC CAD IVL IDE Study, you'll have 4 follow-up visits with a dedicated team of specialists who will focus on your care for 2 years after your treatment with the Coronary IVL System. These visits can be done in person or over the phone.

Before you are enrolled

Before you can join the TECTONIC CAD IVL IDE Study, you'll go through a screening process to make sure you're a good candidate. 

The screening may include:

• Medical History Review: A member of the study team will go over your medical history with you.
• Laboratory Tests: You will have some lab tests done.
• Electrocardiogram (ECG): This test checks your heart's electrical activity.
• Cardiac Biomarker (Troponin) Enzyme Test: This test measures specific enzymes in your blood to check your heart health.
• Coronary Angiography: This test looks for any calcium buildup in your coronary arteries.

What happens if you pass the screening process and register in the study?

If you pass the screening and decide to join the study, remember that participation is completely voluntary. You'll undergo the IVL procedure with the Coronary IVL System. After the procedure, you'll have 4 follow-up visits over the next 2 years at these times:

• 1 month after treatment
• 6 months after treatment
• 1 year after treatment
• 2 years after treatment

These visits can be done in person or over the phone.

NOTE: If you decide to leave the study at any time, you will still receive standard medical care. Choosing not to participate or withdrawing from the study will not result in any penalties or loss of benefits for your future medical care.

What happens if you don’t pass the screening process?

If you do not pass screening, you will not be registered in the study and you will have no follow-up visits.