coronary artery disease coronary artery narrowing
Conditions
Interventions
The Coronary Lithoplasty System is a proprietary balloon catheter system
designed to deliver a lithotripsy device through the coronary arterial system
of the heart to the site of an otherwise diffic
Sponsors
Shockwave Medical Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects are required to meet all of the following inclusion criteria in order to be included in this study.;Inclusion Criteria 1. Patient is >= 18 years of age 2. Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure OR if troponin is elevated, concomitant CK must be normal 3. The target vessel must have a TIMI flow 3 at baseline 4. Patients with significant (>= 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI 5. Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life 6. 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 =50% 5. Calcification within the lesion on both sides of the vessel 6. Ability to pass a 0.014* guidewire across the lesion
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria will not be included in this study.;Exclusion Criteria 1. Concomitant use of Atherectomy, specialty balloon, or investigational coronary devices 2. Prior PCI procedure within the last 30 days of the index procedure 3. Patient has planned cardiovascular interventions within 30 days post index procedure 4. Second lesion with >=50% stenosis in the same target vessel 5. Left ventricular ejection fraction 180 mm Hg or diastolic BP >110 mm Hg) 8. Severe renal failure with serum creatinine >2.5 mg/dL, unless on chronic dialysis 9. Untreated pre-procedural hemoglobin 1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment) 11. Patients in cardiogenic shock 12. Acute myocardial infarction (MI) within the past one (1) month, and/or signs of active myocardial ischemia at the time of enrollment including elevated Troponin-I or T (with concomitant elevation of CK), ischemic ECG changes or chest pain 13. History of a stroke or transient ischemic attack (TIA) within 3 months 14. NYHA class III or IV heart failure 15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months 16. Patients with a life expectancy of less than 1 year 17. Target vessel 32 mm in length 19. Chronic Total Occlusion (CTO) 20. Previous stent procedure within 5 mm of target lesion 21. Angiographic evidence of a target lesion severe dissection prior to Coronary Lithoplasty treatment 22. Unprotected Left Main diameter stenosis >= 50% 23. Visible thrombus (by angiography) at target lesion site 24. Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass 25. Patient has active systemic infection 26. Patient has connective tissue disease (e.g., Marfan*s syndrome) 27. Patient has a hypercoagulable disorder 28. Uncontrolled insulin dependent diabetes 29. Patient has allergy to imaging contrast media for which they cannot be pre-medicated 30. Evidence of aneurysm in target vessel 31. Patient is pregnant or nursing;Angiographic Exclusion Criteria Patients that do not meet the final angiographic eligibility criteria will be documented as angiographic screen failures and will not be considered enrolled into the study and no data collection will be completed. Only patients that meet final angiographic eligibility criteria will be enrolled into the study and undergo treatment with the study device and followed per the clinical protocol with data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endoint: In-hospital major adverse cardiac events (MACE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance will be assessed by the ability of the Lithoplasty System to produce acceptable residual stenosis ( | — |
Countries
Netherlands
Outcome results
None listed