Shockwave Coronary Lithoplasty Study

This is an interventional treatment trial for Coronary Stenosis focused on measuring coronary artery disease, calcified lesions, lithotripsy Read More

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 disease including 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 diameter and ≤ 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 of the 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 chronic single 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 of enrollment)
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 Shockwave device
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