Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)

Study Overview
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Brief Summary
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The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.

Detailed Description
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The study will be conducted at 15 sites in Europe and up to 120 participants will be followed for 30 days post procedure. Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1) cardiac related death, 2) heart attack, and 3) intervention to treat the coronary artery that was previously treated at the procedure visit.

Official Title
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Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: IVL Coronary Lithotripsy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 18 years of age Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure OR if troponin is elevated, concomitant CK must be normal The target vessel must have a TIMI flow 3 at baseline Patients with significant (≥ 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor) for 1 year and single antiplatelet therapy for life Single lesion stenosis of protected LMCA, or LAD, RCA or LCX artery ≥50% in a reference vessel of 2.5 mm - 4.0 mm diameter and ≤ 32 mm length Presence of calcification within the lesion on both sides of the vessel as assessed by angiography Planned treatment of single lesion in one vessel Ability to pass a 0.014 guide wire across the lesion Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures Patient is able and willing to comply with all assessments in the study Exclusion Criteria: Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices Prior PCI procedure within the last 30 days of the index procedure Patient has planned cardiovascular interventions within 30 days post index procedure Second lesion with ≥50% stenosis in the same target vessel Left ventricular ejection fraction < 40% Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg) Severe renal failure with serum creatinine >2.5 mg/dL, unless on chronic dialysis Untreated pre-procedural hemoglobin <10 g/dL Coagulopathy manifested by platelet count <100,000 or International Normalized ratio (INR) >1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment) Patients in cardiogenic shock Acute myocardial infarction (MI) within the past one (1) month, and/or signs of active myocardial ischemia at the time of enrollment including elevated Troponin-I or T (with concomitant elevation of CK), ischemic ECG changes or chest pain History of a stroke or transient ischemic attack (TIA) within 3 months NYHA class III or IV heart failure Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months Patients with a life expectancy of less than 1 year Target vessel < 2.4 mm in diameter Target lesion > 32 mm in length Chronic Total Occlusion (CTO) Previous stent procedure within 5 mm of target lesion Angiographic evidence of a target lesion severe dissection prior to Coronary Lithoplasty treatment Unprotected Left Main diameter stenosis ≥ 50% Visible thrombus (by angiography) at target lesion site Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass Patient has active systemic infection Patient has connective tissue disease (e.g., Marfan's syndrome) Patient has a hypercoagulable disorder Uncontrolled insulin dependent diabetes Patient has allergy to imaging contrast media for which they cannot be pre-medicated Evidence of aneurysm in target vessel Patient is pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Intravascular Coronary Lithotripsy System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVL Coronary Lithotripsy System<br>All enrolled patients will receive treatment from the IVL coronary lithotripsy system prior to coronary stent placement. | Device: IVL Coronary Lithotripsy System<br>* The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) | The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following: Cardiac death Myocardial Infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure | Post-procedure through hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Success | Performance will be assessed by the ability of the Lithotripsy System to produce acceptable residual stenosis (<50%) after stenting with no evidence of in-hospital MACE. Each patient that achieves both of these requirements will be considered a clinical success, and the rate of clinical success among subjects will be evaluated. | During procedure through hospital discharge | 
| Number of Participants With Angiographic Success | Angiographic success defined as success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. | During procedure | 
| Number of Participants Which Experienced Cardiac Death | Number of patients who experienced a cardiac death at 30 days post-procedure. | 30 days post-procedure |