Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)

Prospective, Multicenter, Single-Arm IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD Duo Study)

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.

The Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

Up to 145 subjects (138 evaluable) subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) will be enrolled at up to 20 US sites.

Enrollment duration will be approximately 10-12 months and study duration will be approximately 2 years.

Each subject will be followed through discharge, 30 days, 6, and 12 months.

Inclusion Criteria:Subjects are required to meet all of the following inclusion criteria in order to be enrolled in the clinical study.

General Inclusion Criteria

1. Subject is ≥18 years of age

2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI

3. 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)

4. 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

   1. 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)
   2. 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

5. 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)

6. Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures

7. Non-target lesions requiring PCI may be treated either

   1. >30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
   2. >24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis <30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and with no post-procedure biomarker elevation >normal; or
   3. >30 days after the study procedure

   Angiographic Inclusion Criteria

8. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure

9. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with

   1. Stenosis of ≥70% and <100%, or
   2. Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm2

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

11. The lesion length must not exceed 40 mm

12. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre- dilatation)

13. Evidence of calcification at the lesion site by, a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section

14. Ability to pass a 0.014" guide wire across the lesion

Exclusion Criteria: Subjects who meet any of the following exclusion criteria may not be enrolled in the study:

General Exclusion Criteria

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

2. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint

3. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)

4. Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines

5. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated

6. 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

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

8. Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73m2 (using CKD-EPI formula)

9. History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit

10. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months

11. Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary

12. 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)

13. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other related blood disorders

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

15. Subjects with clinical evidence of cardiogenic shock

16. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)

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

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

19. Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure

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

21. Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy

    Angiographic Exclusion Criteria

22. Unprotected left main diameter stenosis >30%

23. Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel

24. Evidence of aneurysm in target vessel within 10 mm of the target lesion

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

26. Previous stent within 5 mm of the target lesion regardless of the timing of its implantation

27. Angiographic evidence of a dissection or perforation in the target vessel at baseline or after guidewire passage