Abbott's Coronary IVL IDE Study

A prospective, single-arm, multi-center Coronary IVL IDE Study with 47 US sites

The Coronary IVL study is a prospective, single-arm, open-label, multi-center study to evaluate the safety and effectiveness of the Abbott IVL System to treat severely calcified, stenotic de novo coronary arteries prior to stenting in 335 subjects at 47 sites in the US. The clinical outcomes from the Coronary IVL IDE study will be compared to pre-specified performance goals (PG) established using medical/scientific literature. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the Abbott Coronary IVL System in the United States.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be at least 18 years of age.
2. Subject must sign and date a written informed consent form before any study-specific tests or procedures are performed.
3. Subject is able and willing to comply with all protocol requirements.
4. Subject has native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI.
5. For subject with unstable ischemic heart disease, cardiac biomarker (troponin) must be less than or equal to the upper reference limit (URL) within 12 hours prior to the procedure.
6. For subject with stable ischemic heart disease, blood for cardiac biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath.

6a. If drawn prior to the procedure, cardiac biomarker (troponin) must be less than or equal to the URL within 12 hours prior to the index procedure.

6b. If drawn at the time of the procedure from the side port of the sheath prior to any intervention, cardiac biomarker results need to be analyzed and resulted prior to registering the subject into the study.

7) Left ventricular ejection fraction (LVEF) ≥ 25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for these criteria; may be assessed at time of index procedure).

8) Lesions in non-target vessels requiring PCI may be treated either: a. \>30 days prior to the study procedure if the procedure was unsuccessful or complicated; or b. \>24 hours prior to the study procedure if the procedure was successful and uncomplicated; or c. \>30 days after the study procedure (in 1 or 2 non-target vessels).

Anatomic Inclusion Criteria

Anatomic inclusion criteria are applied at the time of cardiac catheterization for PCI by the investigator and are visually assessed by angiography. The anatomic inclusion criteria include the following:

1. The target lesion must be a single de novo coronary lesion that has not been previously treated with ANY interventional procedure.
2. Single de novo target lesion stenosis of protected left main coronary artery (LMCA), or left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with: a. Stenosis of ≥70% and \<100% or b. Stenosis ≥50% and \<70% with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or RFR/iFR \<0.89 (or any other non-hyperemic pressure index), or IVUS or OCT minimum lumen area ≤4.0 mm\^2
3. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm.
4. The lesion length must not exceed 36 mm. 4a) Tandem lesions are allowed and considered one lesion if they are \<5 mm apart and as long as the total lesion length does not exceed 36 mm.
5. The target vessel must have TIMI grade 3 flow at baseline; may be assessed after pre-dilatation.
6. Evidence of calcification at the lesion site by, a. Angiography, with fluoroscopic radiopacities noted as severe (radiopacities noted without cardiac motion before contrast injection compromising both sides of the arterial lumen) OR b. IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section.
7. Ability to pass a 0.014" guide wire across the lesion.

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 30 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 \<10 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 non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days prior to the index procedure.
21. Subject has planned non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures 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

Anatomic Exclusion Criteria

Anatomic exclusion criteria are applied at the time of cardiac catheterization for PCI by the investigator and are visually assessed by angiography. The anatomic exclusion criteria include the following:

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 (LAD, RCA, LCX, or RI, within 5 mm of ostium) or an unprotected LMCA lesion.
7. Target lesion is a bifurcation with ostial diameter stenosis ≥30%.
8. Second lesion with \>50% stenosis in the same target vessel as the target lesion, including its side branches 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