Prospective Randomized 1:1 Multi-Center Clinical Trial designed to Evaluate Orbital Atherectomy (OA) vessel preparation compared to conventional angioplasty technique for the treatment of severely calcified coronary artery lesions.

Brief description of study

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.

Clinical Study Identifier: s19-00570 Identifier: NCT03108456

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