TECTONIC CAD IVL IDE Study

What is the Study Device?

The device being tested is called the Abbott Coronary IVL System. This system uses a special technique called intravascular lithotripsy to break up hard calcium in your arteries and prepare them for placing a stent.

What Does the Device Include?

• IVL Console: This is a reusable machine that controls and powers the system. It helps break up the hard calcium buildup in your blood vessels.
• Coronary IVL Catheter: This is a thin, flexible tube that delivers the treatment to the exact spot in your blood vessel where it's needed.

How Does It Work?

The Coronary IVL System uses sound waves to break up the hard calcium buildup in your blood vessels. This makes it easier for your doctor to treat the blood vessel and place a stent more effectively.

Effect of the Treatment

When the Coronary IVL System is powered up, it creates sound waves called lithotripsy. These sound waves travel to the treatment area in your coronary artery and break up the hard calcium buildup in your blood vessel. This helps prepare the artery for placing a stent.

Summary of the Treatment Procedure

1. Placing the Catheter: A thin, flexible tube called the IVL catheter is placed in the area of your blood vessel that has hard calcium buildup.
2. Inflating the Balloon: The balloon on the catheter is then inflated.
3. Delivering Sound Waves: The IVL system sends out pulses of sound waves to break up the calcium in the targeted area.
4. Placing the Stent: Once the calcium is broken up and the blood vessel is prepared, a stent is placed in the treated area to keep the artery open.

What Happens After the Treatment?

After your treatment, it's important to follow the schedule your doctor gives you. You'll have 4 follow-up visits over the next 2 years:

• 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.

Medications

You'll need to take special medications called dual antiplatelet therapy (DAPT) for at least 30 days after your treatment. These medications help prevent blood clots in your arteries. DAPT includes aspirin and another medication like clopidogrel, prasugrel, or ticagrelor. After the first 30 days, your doctor might recommend continuing this therapy for a longer period.

Patient Resources

We offer several resources to help you with your follow-up visits for the TECTONIC CAD IVL IDE Study. These include:

• Phone Follow-Up Visits: You can have your follow-up visits over the phone if that's more convenient for you.
• Patient Stipends and Transportation Reimbursement: We may provide financial support to cover your travel expenses.
• Child and Adult Care: Assistance with care for your children or other dependents may be provided during your visits.
• Time-Off Work Letters: We may provide letters to help you get time off work for your appointments.
• Translator Support: If you need help with translation, we may provide support to ensure you understand everything clearly.