Coronary Flow Reserve Following Orbital Atherectomy

Subjects must meet all inclusion criteria and no exclusion criteria to be eligible to participate in the study.

Inclusion Criteria

• Subjects must be at least 18 years of age.
• Subjects must be scheduled for percutaneous coronary intervention involving stent deployment in de novo coronary lesions.
• The target vessel must be a de-novo coronary artery with a severely calcified lesion.
• The target vessel reference diameter must be ≥ 2.0mm and ≤ 4.0 mm.
• The lesion length must not exceed 40 mm.
• The target vessel must have a thrombolysis in myocardial infarction (TIMI) flow 3 at baseline.
• The target lesion must have fluoroscopic, intravascular ultrasound (IVUS) or optical coherence tomograph (OCT) evidence of severe calcium deposit at the lesion site based on the protocol definition.
• The lesion must be crossable with the ViperWire Advance® coronary guide wire.
• Successful revascularization using OAS and stent deployment as demonstrated by no evidence of stent dissection and no more than 50% stenosis proximal to the stent.

Exclusion Criteria

• Inability to understand the study or a history of non-compliance with medical advice.
• Unwilling or unable to sign the informed consent form (ICF).
• History of any cognitive or mental health status that would interfere with study participation.
• Currently enrolled in any pre-approval investigational study. Note: This does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints.
• Female subjects who are pregnant or planning to become pregnant within the study period.
• Previous myocardial infarction of the target vessel.
• Known sensitivity to contrast media, which cannot be adequately pre-medicated.
• Diagnosed with chronic renal failure or has a serum creatinine level > 2.5 mg/dl.
• History of a stroke or transient ischemic attack (TIA) within six (6) months of the procedure.
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within six (6) months of the procedure.
• Wall motion abnormality in the intended vessel target zone.
• Severe chronic obstructive pulmonary disease (COPD), asthma or current use of the medication: aminophylline.
• 2nd or 3rd degree atrioventricular (AV) block.
• Evidence of current left ventricular ejection fraction (LVEF) ≤45% (where current is defined as the latest LVEF measurement completed within the last 6 months).
• New York Heart Association (NYHA) class III or IV heart failure.
• Previous coronary artery bypass surgery.
• Known allergy to atherectomy lubricant components such as soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
• Severe aortic stenosis.
• Severe left ventricular hypertrophy.
• Subject with angiographically confirmed evidence of more than 1 lesion requiring intervention.
• Target vessel has other lesions with greater than 50% diameter stenosis based on visual estimate or on-line quantitative coronary analysis (QCA).
• Target vessel has angiographically visible or suspected thrombus.
• Target vessel has a stent from previous PCI unless:
• The stent was implanted greater than 30 days prior to the treatment, and
• The stent has no higher than 30% in-stent stenosis, and
• The stent is on a different branch than the target lesion.
• Target vessel is excessively tortuous.
• Target lesion is an ostial location (within 5 mm of ostium) or an unprotected left main lesion.
• Target lesion is a bifurcation.
• Target lesion has a ≥ 1.5 mm side branch.
• Angiographic evidence of a dissection prior to initiation of orbital atherectomy device (OAD).
• Angiographic evidence of MACE during procedure.