Intravascular Lithotripsy in Comparison to Rotational Atherectomy: An Evaluation by OFDI

Inclusion Criteria:

1. Patient ≥ 18 years old

2. Subjects with native coronary artery disease (including stable or unstable anginaand silent ischemia) suitable for Percutaneous Coronary Intervention (PCI)

3. For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB)must be less than or equal to the upper limit of the lab (URL) normal within 12hours prior to the procedure

4. The target lesion must be a de novo coronary lesion that has not been previouslytreated with any interventional procedure

5. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA, or LCX (or oftheir branches) with:

6. Stenosis of ≥70% and <100%

7. or Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia viapositive stress test, or fractional flow reserve value ≤0.80

8. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm

9. The lesion length must not exceed 40 mm

10. The target vessel must have TIMI flow 3 at baseline

11. Evidence of calcification at the lesion with a B or C Mintz classification site: B: Moderate calcification: radiopacities are noted only during the cardiac cyclebefore contrast injection C: severe calcification: radiopacities are seen withoutcardiac motion, also before contrast injection, usually affecting both sides of thearterial lumen.

12. Ability to pass a 0.014" guidewire across the lesion

13. Ability to cross target lesion with a 2 mm balloon

14. Patient insured under the French healthcare system ("Régime National AssuranceMaladie")

15. Lesions in non-target vessels requiring PCI may be treated either:

• a. >30 days prior to the study procedure if the procedure was unsuccessful orcomplicated; or

• b. >24 hours prior to the study procedure if the procedure was successful anduncomplicated (defined as a final lesion angiographic diameter stenosis <30%and TIMI 3 flow (visually assessed) for all non-target lesions and vesselswithout perforation, cardiac arrest or need for defibrillation or cardioversionor hypotension/heart failure requiring mechanical or intravenous hemodynamicsupport or intubation, and with no post-procedure biomarker elevation >normal;or

• c. >30 days after the study procedure d. Could be treated in the same time ofthe diagnosis coronarography with respect of the delay for the index procedureof the protocol as described above

14. Patient able to assess and understand the risks and benefits, to accept andparticipate in the study (by signing an informed consent form and knowledgeable ofthe information letter).

15. Patient accepting the appropriate follow-up as per study definition

Exclusion Criteria:

1. Patient age < 18 years

2. The subject is pregnant or nursing

3. Patient refusing to participate in the study or unable to give informed consent (Guardianship, curatorship or judicial safeguard)

4. Any comorbidity or condition which may reduce compliance with this protocol,including follow-up visits

5. The protected subject according to the current legislation (articles L.1121-5 toL.1121-8 of the French Code of Public Health).

6. The subject is participating in another research study involving an investigationalagent (pharmaceutical, biologic, or medical device), unless it is authorized by theconcomitant study protocol.

7. Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel,prasugrel, or ticagrelor) for at least 6 months

8. The subject has an allergy to imaging contrast media which cannot be adequatelypre-medicated

9. The subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior toindex procedure, defined as a clinical syndrome consistent with an acute coronarysyndrome with troponin or CK-MB greater than 1 time the local laboratory's uppernormal limit

10. New York Heart Association (NYHA) class III or IV heart failure

11. History of a stroke or Transient Ischemic Attack (TIA) within 6 months, or any priorintracranial hemorrhage

12. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months

13. Uncontrolled diabetes defined as an HbA1c >10%

14. Subjects in cardiogenic shock

15. Subject has an active systemic infection on the day of the index procedure witheither fever, leukocytosis or requiring intravenous antibiotics

16. Subjects with a life expectancy of less than 1 year

17. Non-coronary interventional or surgical structural heart procedures (e.g., TAVR,MitraClip, LAA, or PFO occlusion…) within 30 days prior to the index procedure

18. Planned non-coronary interventional or surgical structural heart procedures (e.g.,TAVR, MitraClip, LAA or PFO occlusion...)

19. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery

20. High SYNTAX Score (≥33) if assessed as a standard of care, unless the local heartteam has met and recommends PCI is the most appropriate treatment for the patient

21. Definite or possible thrombus (by angiography or intravascular imaging) in thetarget vessel

22. Evidence of aneurysm in target vessel within 10 mm of the target Lesion

23. Unprotected left main

24. Target lesion is located in a native vessel that can only be reached by goingthrough a saphenous vein or arterial bypass graft

25. Angiographic evidence of dissection in the target vessel at baseline or afterguidewire passage

26. Ejection fraction less than 30 % evaluated in TTE, angiography or MRI

27. Patient suffering of lymphoma, leukemia and other malignancies

28. Patient suffering of liver disease