The objective of the PINNACLE I Clinical Study is to assess safety and performance of the LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX) to treat moderately to severely calcified coronary artery lesions by calcium fragmentation utilizing Hertzian contact stress from LithiX HCIVLC.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is ≥ 18 years of age.
✓. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
✓. Subject must agree not to participate in any other clinical study during the course of the study that would interfere with the endpoints of this study.
✓. Subjects must have a single or double vessel coronary artery disease (CAD) and clinical evidence of ischemic heart disease, such as CAD, silent ischemia, stable / unstable angina, and NSTEMI if biomarkers are stable or falling at time of inclusion.
✓. Subject must have de novo lesion(s) in native coronary arteries suitable for percutaneous coronary intervention.
✓. Up to 2 de novo coronary artery lesions in separate epicardial vessels, which are moderately to severely calcified, meeting all of the following criteria visually assessed by angiography:
✓. Any non-target lesion must be located in different coronary artery from a target lesion. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician.
Exclusion criteria
✕. Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated.
✕. Subject with known diagnosis of STEMI at index presentation or within 7 days of study screening.
. Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery.
✕. Subject with known pregnancy or is nursing. Women of child-bearing potential should have a documented negative pregnancy test within 7 days before index procedure.
✕. Planned use of atherectomy, laser, lithoplasty, thrombectomy, scoring or cutting balloon, or any investigational device other than LithiX in the target lesion during the index procedure.
✕. Patients on renal dialysis or with known eGFR \< 30 ml/min.