Shockwave Coronary Lithoplasty Study

Inclusion Criteria:

1. At least 18 years of age and able to give informed consent.

2. Patients in Sinus Rhythm.

3. Patients with significant (> 50% diameter stenosis) native coronary artery diseaseincluding stable or unstable angina and silent ischemia, suitable for PCI.

4. Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel or prasugrel).For 1 year and single therapy for life.

5. Patient is able and willing to comply with all assessments in the study.

6. Stenosis of LAD, RCA or LCX artery ≥50% in a reference vessel of 2.5mm-3.5 mm diameterand ≤ 22 mm length, as assessed by two orthogonal angiographic views.

7. Calcification with parallel calcium at least 50% the length of the lesion.

8. At the time of the procedure the subject is in Sinus Rhythm.

9. Single lesions per vessel.

10. Ability to pass a 0.014" guide wire across the lesion.

Exclusion Criteria:

1. Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.

2. Additional planned coronary interventions for a non-target lesion within 180 days ofthe study procedure.

3. Left ventricular ejection fraction < 40%

4. Patients refusing or not candidates for emergency coronary artery bypass grafting (CABG) surgery

5. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)

6. Patients who are not candidates for dual anti-platelet therapy for 30 days and chronicsingle anti-platelet therapy

7. Severe renal failure with creatinine >2.5 mg/dL

8. Untreated pre-procedural hemoglobin <10 g/dL

9. Coagulopathy manifested by platelet count <100,000 or International Normalized ratio (INR) >1.7 (INR is only required in patients who have taken warfarin within 2 weeks ofenrollment)

10. Patients in cardiogenic shock

11. Acute myocardial infarction (MI) within the past one (1) month, and/or elevated CPK (and abnormal Troponin-I) at the time of enrollment

12. Patients with a life expectancy of less than 1 year

13. Target main branch vessel < 2.5 mm in diameter

14. Target main branch lesion > 22 mm in length

15. Chronic Total Occlusion (CTO).

16. Previous stent procedure within 10 mm of target lesion

17. Prior PCI procedure within the last 6 months.

18. Target lesion demonstrating severe dissection prior to planned use of the Shockwavedevice

19. Unprotected Left Main diameter stenosis ≥ 50%

20. Visible thrombus (by angiography) at target lesion site

21. Patient has active systemic infection

22. Patient with an externally-connected intracardiac catheter or pacemaker.

23. Patient with an implantable pacemaker or defibrillator.

24. Patient has connective tissue disease (e.g., Marfan's syndrome)

25. Patient has a hypercoagulable disorder.

26. Patient has allergy to imaging contrast media for which they cannot be pre-medicated.

27. Evidence of aneurysm or acute thrombus in target vessel.

28. Patients with prior sternotomy as a result of thoracic surgery