The Sapphire 3 CTO Study is designed to test a device called a coronary dilatation catheter. This small tube helps open blocked heart arteries during a procedure known as percutaneous coronary intervention (PCI). This study will involve 170 patients at 15 locations. The aim is to see how safe and effective the catheter is when used on arteries that have been blocked for a long time, called Chronic Total Occlusion (CTO).
Participants must be 18 or older, and able to give consent. They should not join other studies while participating. The study ends 24 hours after the procedure or when the patient leaves the hospital. Patients with recent heart attacks, kidney issues, or certain allergies may not join. Pregnant or nursing women are also excluded.
- Study involves one hospital visit for the procedure.
- Participants will be monitored for 24 hours after the procedure.
- Key risks include reactions to medications or procedure-related complications.