Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)

Inclusion Criteria

• Patient is ≥ 18 years of age
• Troponin must be less than or equal to the upper limit of lab normal value within 12 hours prior to the procedure
• The target vessel must have a TIMI flow 3 at baseline
• Patients with significant (≥ 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
• Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life
• Single lesion stenosis of protected LMCA, or LAD, RCA or LCX artery ≥50% in a reference vessel of 2.5 mm - 4.0 mm diameter and ≤ 32 mm length
• Presence of calcification within the lesion on both sides of the vessel as assessed by angiography
• Planned treatment of single lesions in one vessel
• Ability to pass a 0.014" guide wire across the lesion
• Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
• Patient is able and willing to comply with all assessments in the study

Exclusion Criteria

• Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices
• Prior PCI procedure within the last 30 days of the index procedure
• Patient has planned cardiovascular interventions within 30 days post index procedure
• Second lesion with ≥50% stenosis in the same target vessel
• Left ventricular ejection fraction 180 mm Hg or diastolic BP >110 mm Hg)
• Severe renal failure with serum creatinine >2.5 mg/dL
• Untreated pre-procedural hemoglobin 1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment)
• Patients in cardiogenic shock
• Acute myocardial infarction (MI) within the past one (1) month, and/or elevated Troponin-I or T (with concomitant elevation of CPK) at the time of enrollment.
• History of a stroke or transient ischemic attack (TIA) within 3 months
• NYHA class III or IV heart failure
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
• Patients with a life expectancy of less than 1 year
• Target vessel 32 mm in length
• Chronic Total Occlusion (CTO)
• Previous stent procedure within 5 mm of target lesion
• Angiographic evidence of a target lesion severe dissection prior to Coronary Lithoplasty treatment
• Unprotected Left Main diameter stenosis ≥ 50%
• Visible thrombus (by angiography) at target lesion site
• Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass
• Patient has active systemic infection
• Patient has connective tissue disease (e.g., Marfan's syndrome)
• Patient has a hypercoagulable disorder
• Uncontrolled insulin dependent diabetes
• Patient has allergy to imaging contrast media for which they cannot be pre-medicated
• Evidence of aneurysm in target vessel
• Patient is pregnant or nursing