TECTONIC CAD IVL IDE Study

Exclusion Criteria

• •1. Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
• •2. Subject is a member of a vulnerable population including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
• •3. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the Primary endpoint. For the purposes of this criterion, "participation" is defined as being registered in another trial.
• •4. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. For subjects with childbearing potential, a urine or blood pregnancy test is required within 7 days prior to index procedure to verify that subject is not pregnant. Note: Investigators should instruct female patients of childbearing potential to use safe contraception for 12 months after the procedure (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release). It is acceptable to include subjects having a sterilized regular partner.
• •5. Subject unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months.
• •6. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated.
• •7. Subject experienced an acute MI (either ST-segment elevation myocardial infarction, STEMI or non-ST-segment elevation myocardial infarction, NSTEMI) within 7 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK- MB greater than 1 times the local laboratory's ULN.
• •8. Subject has New York Heart Association (NYHA) class III or IV heart failure.
• •9. Subject has renal failure with serum creatinine \>2.5 mg/dL, or chronic dialysis.
• •10. Subject has a history of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit.
• •11. Subject has an active peptic ulcer or upper gastrointestinal bleeding within 6 months.
• •12. Subject has an untreated pre-procedural hemoglobin \<8 g/dL or intention to refuse blood transfusions if one should become necessary.
• •13. Subject has a coagulopathy, including but not limited to platelet count \<100,000 or International Normalized ratio (INR) \>1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment).
• •14. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count \>750,000 or other disorders.
• •15. Subject has uncontrolled diabetes defined as a HbA1c ≥10%.
• •16. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics.
• •17. Subject in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia).
• •18. Subject has uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg).
• •19. Subject with a life expectancy of less than 1 year.
• •20. Subject has had interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure.
• •21. Subject has planned interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure.
• •22. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery.
• •23. Subject has a previous stent in the target vessel implanted within the last year.
• •24. Planned use of atherectomy, scoring or cutting balloon, ultra-high pressure non-compliant balloon, excimer laser coronary atherectomy (ELCA), drug-coated balloon (DCB) or any investigational device other than the current study device
• •1. Unprotected LMCA diameter stenosis \>30%.
• •2. Target lesion has a myocardial bridge.
• •3. Target vessel is excessively tortuous, defined as the presence of 2 or more bends \>90 degrees or 3 or more bends \>75 degrees.
• •4. Definite or possible thrombus in the target vessel.
• •5. Evidence of aneurysm in target vessel within 10 mm of the target lesion.
• •6. Target lesion in ostial location (within 5 mm of the vessel origin) of the LMCA, LAD, LCX, or RI and per the physician's discretion would require stenting into the LMCA.
• •7. Target lesion is a bifurcation with the side branch having ostial diameter stenosis ≥50% and is an intervenable target (e.g. ≥2.0mm in diameter).
• •8. Second lesion with \>50% stenosis in the same target vessel as the target lesion, including planned treatment of side branches and distal lesions that are ≥2.0 mm in diameter.
• •9. Target lesion is located in a native vessel that can only be reached by going through an existing coronary artery bypass graft.
• •10. Any previous stent within 10 mm of the target lesion.
• •11. Imaging evidence of a dissection (NHLBI dissection grades D-F) in the target vessel after guide wire passage and/or prior to start of IVL treatment