What is the Purpose of this Study?
This study focuses on people whose arteries around the heart have significant narrowing or blockage and whose doctor has recommended treatment with percutaneous coronary intervention (PCI) and lithotripsy procedure. The purpose of the study is to demonstrate the safety and effectiveness of an experimental device called the Bolt Intravascular Lithotripsy (IVL) System when used during standard-of-care PCI and lithotripsy procedure. The procedure is performed to open narrowed or hardened heart arteries, and a stent is placed to improve blood flow. The Bolt IVL System is used to help prepare the artery by breaking up hardened calcium before the stent is placed. The system consists of a balloon catheter, which is a thin tube with a small balloon and special tips at the end, and a console, which is a machine that sends energy to the catheter. All participants will receive the Bolt Intravascular Lithotripsy (IVL) System. Study procedures also include medical records review, electrocardiogram and/or other imaging, physical exam, and blood draws.
Eligibility
- * Subject is ≥18 years of age;
- * Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for Percutaneous Coronary Intervention (PCI);
- * For patients with unstable ischemic heart disease, a local site-based biomarker (preferably troponin or hs-troponin) must be less than or equal to the upper limit of lab normal (ULN) within 12 hours prior to the study procedure;
- * For patients with stable ischemic heart disease, CK-MB will be drawn at the time of the study procedure from the side port of the sheath; results need not be analyzed prior to enrollment, but must be less than or equal to the upper limit of lab normal (ULN);
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
ModiFication of coRonAry Calcium with laser based inTravascUlaR lithotripsy for coronary artEry disease