The purpose of this trial is to evaluate orbital atherectomy vessel preparation compared to standard angioplasty prior to placing a stent for the treatment of CAD. The Diamondback 360® Coronary Orbital Atherectomy System (OAS) uses a diamond-coated crown that spins back and forth inside your blocked artery (blood vessel) to sand and reduce the calcium. Atherectomy is the medical term describing the removal of plaque from the arteries. The use of the OAS is called orbital atherectomy (OA). Standard angioplasty will allow vessel preparation with any device, except for atherectomy, that has been approved or cleared by the Food and Drug Administration (FDA) for treating CAD. None of the devices used in this trial are experimental.
After you have signed the consent form, tests will be performed to make sure you qualify for the trial prior to your heart procedure. A majority of these tests and/or procedures are standard of care and may be done even if you do not participate in the clinical trial. If you have had some of the required tests performed recently, they may not need to be repeated. You will undergo a physical examination, an electrocardiogram (ECG) (measurement of your heart rhythm), pregnancy test (for women of childbearing potential) and a blood draw. Your clinical trial doctor will also ask you about your medical history. A Quality of Life (QoL) questionnaire will be completed to collect information about how your heart condition affects your daily life. Even if you sign this consent, you may not be included in the trial if your test results do not match the requirements of the clinical trial or if your doctor decides that a different treatment would be better for you. Images will be collected of your arteries (vessels). Images of your arteries can be taken three different ways: Angiography, Intravascular Ultrasound (IVUS), and Optical Coherence Tomography (OCT). Angiography uses a dye that is injected through a catheter (tube) and then uses an x-ray to image the arteries in your heart. IVUS uses an ultrasound probe on the end of a catheter to give the doctor a view from inside the vessel. OCT is the most advanced imaging method of the three and uses light at the end of the catheter to capture three-dimensional images from within the vessel. These different types of imaging can provide information about your blockage or narrowing, including the presence of calcium.