Condition: Coronary artery disease
Key Inclusion Criteria:
- At least 18 years old
- Has stable ischemic heart disease, acute coronary syndrome, or stabilized recent ST-segment elevation myocardial infarction (STEMI)
Key Exclusion Criteria:
- History of any cognitive or mental health status that would interfere with trial participation
- Participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint
Evaluation of Treatment Strategies for Severe Calcific Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting Stents (ECLIPSE) (IRB no. PRO00049206)
This study focuses on individuals who may have vessels in the heart that are partly blocked (a condition known as coronary artery disease or CAD) and are scheduled for a heart procedure to help fix the blockage. The purpose of the study is to evaluate two blood vessel preparation strategies prior to stent placement for the treatment of CAD. Researchers aim to determine how each treatment affects long-term health.
Specifically, the study will evaluate orbital atherectomy vessel preparation compared to standard angioplasty before stent placement. The Diamondback 360 Coronary Orbital Atherectomy System uses a diamond-coated crown that spins back and forth inside the blocked artery (blood vessel) to sand and reduce the calcium. (Atherectomy is a term describing the removal of plaque from the arteries.) Standard angioplasty will allow vessel preparation with any device, except for atherectomy, that has been approved or cleared by regulatory authorities. None of the devices used in this trial are experimental.