This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is ≥18 years of age
✓. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
✓. For subjects with unstable ischemic heart disease, biomarkers (CK-MB and troponin) must be less than or equal to the upper limit of the laboratory normal within 12 hours prior to the procedure (note: both must be normal)
✓. For subjects with stable ischemic heart disease, biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath
✓. If drawn prior to the procedure, biomarkers (CK-MB and troponin) must be less than or equal to the upper limit of the laboratory normal within 12 hours of the procedure (note: both must be normal)
✓. If drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analyzed prior to enrollment
✓. Left ventricular ejection fraction \>25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criterion; may be assessed at time of index procedure)
✓. Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
Exclusion criteria
✕. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
✕
What they're measuring
1
Percentage of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure
Timeframe: within 30 days of index procedure
2
Percentage of Participants With Procedural Success (Residual Stenosis ≤30%)
Timeframe: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
✕. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
✕. Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines
✕. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
✕. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin greater than 1 times the local laboratory's upper limit of normal
✕. New York Heart Association (NYHA) class III or IV heart failure
✕. Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73m2 (using CKD-EPI formula)