arterial stenosis stenotic coronary arteries
Conditions
Interventions
Percutaneous insertion of the Shockwave Coronary Rx Lithoplasty® System for
lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de
novo coronary arteries.
Sponsors
Shockwave Medical Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 12 hours prior to the procedure 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, LAD, RCA or LCX artery *50% in a reference vessel of 2.5 mm - 4.0 mm diameter and * 32 mm length 7. Presence of calcification within the lesion on both sides of the vessel as assessed by angiography 8. Planned treatment of single lesions per vessel 9. Ability to pass a 0.014* guide wire across the lesion 10. Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures 11. Patient is able and willing to comply with all assessments in the study
Exclusion criteria
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 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 elevated Troponin-I or T (with concomitant elevation of CK) at the time of enrollment 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 main branch 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 CONFIDENTIAL * Do Not Duplicate without Permission from Shockwave Medical Shockwave Study Protocol, TD 0257 Revision C Page 11 of 54 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Safety will be assessed by the frequency of major adverse cardiac events (MACE) within 30 days of the procedure. MACE is defined as: * Cardiac death * MI - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure Performance Performance will be assessed by the ability of the Shockwave System to produce acceptable residual stenosis (* 50%) after stenting with no evidence of in-hospital MACE. Each patient that achieves both of these requirements will be considered a *clinical success*, and the rate of clinical success among patients will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Quantitative assessment of the residual stenosis in treated lesions o Angiographic success defined as success in facilitating stent delivery with | — |
Countries
Netherlands
Outcome results
None listed