Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries
- Conditions
- coronary artery diseasecoronary artery narrowing100110821000759310003216
- Registration Number
- NL-OMON46584
- Lead Sponsor
- Shockwave Medical Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
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 <= 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 lesion in one 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;Angiographic Inclusion Criteria
1. Target lesion is located in a native LMCA, LAD, RCA or LCX artery. A single lesion may be treated per protocol
2. Target lesion reference vessel diameter is between 2.5 mm and 4.0 mm (visual estimate)
3. Target lesion is <= 32 mm in length
4. Stenosis of LMCA, LAD, RCA or LCX artery >=50%
5. Calcification within the lesion on both sides of the vessel
6. Ability to pass a 0.014* guidewire across the lesion
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 < 40%
6. Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
7. Uncontrolled severe hypertension (systolic BP >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 <10 g/dL
10. 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)
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 < 2.4 mm in diameter
18. Target lesion > 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Safety Endoint:<br /><br><br /><br>In-hospital major adverse cardiac events (MACE)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Performance will be assessed by the ability of the Lithoplasty System to<br /><br>produce acceptable residual stenosis (<50%) after stenting with no evidence of<br /><br>in-hospital MACE. Each patient that achieves both of these requirements will<br /><br>be considered a *clinical success*, and the rate of clinical success among<br /><br>subjects will be evaluated.<br /><br><br /><br>Angiographic success defined as success in facilitating stent delivery with<br /><br><50% residual stenosis and without serious angiographic complications.<br /><br>Serious angiographic complications are defined as severe dissection (Type D to<br /><br>F), perforation, abrupt closure, and persistent slow flow or persistent no<br /><br>reflow.<br /><br><br /><br>Cardiac death at 30 days.</p><br>