Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)

Study Overview
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Brief Summary
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Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the placement of stents and reducing the ultimate residual stenosis. Patients will be followed through discharge and at 30 and 180 days.

Detailed Description
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Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the placement of stents and reducing the ultimate residual stenosis. Patients will be enrolled and consented in the study based on history and in some instances an angiogram obtained prior to the study. The study is designed to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, coronary arteries. Subjects will be prepared for PCI per the institution's standard protocol. Medications will be administered per the treatment protocol. Femoral access will be obtained using a 6F access sheath, and guiding catheter placed at the ostia of the right or left coronary artery. Baseline angiography of the culprit lesion will be performed prior to placement of a 0.014 guide wire. Baseline and either IVUS or OCT will be performed to determine the Maximum Lumen Area (MLA), percent stenosis, and volumetric lesion assessment. Baseline angiography will be performed to determine lesion length, % stenosis and reference vessel diameter. The investigational device will be prepped per the IFU and positioned at the target lesion. The distal end of the balloon catheter will be connected to the patient cable. The balloon catheter will be inflated to 4 atm and the investigator will deliver 10 pulses for 20 seconds. The balloon will then be inflated to reference vessel diameter and then deflated to reestablish flow and complete one treatment cycle. The treatment cycle will then be repeated. Angiography and either IVUS or OCT will be repeated for the treated lesion.. A coronary stent will be deployed at the site of treatment. Angiography and either IVUS or OCT will be performed following stent placement. Patients will be followed through discharge and at 30 and 180 days. A subset of up to five (5) subjects will receive an angiographic assessment at the 180 day follow up visit, per the Sponsor's discretion.

Official Title
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Prospective Multi-Center, Single Arm Study of the Shockwave Coronary Rx Lithoplasty® System in Coronary Arteries

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Shockwave Coronary Rx Lithoplasty® 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 12 hours prior to the procedure 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 lesions 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 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 elevated Troponin-I or T (with concomitant elevation of CPK) at the time of enrollment. 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lithoplasty System<br>Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement | Device: Shockwave Coronary Rx Lithoplasty® System<br>* The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator.<br>* Other names: Coronary Rx Lithoplasty System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Frequency of Major Adverse Cardiac Events (MACE) Within 30 Days of the Procedure. | MACE defined as: 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 the target lesion) after the completion of the index procedure | 30 days | 
| Performance | The ability of the Shockwave System to produce acceptable residual stenosis (<50%) after stenting with no evidence of in-hospital MACE. Clinical success measured by each patient that achieves both these requirements. | Post-procedure (within 24 hours following procedure and prior to discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Assessment of the Residual Stenosis in Treated Lesions | Angiographic success defined as success in facilitating stent deliver 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 | Post-procedure (within 24 hours following procedure and prior to discharge) | 
| 180 Day MACE | MACE defined as: 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 the target lesion) after the completion of the index procedure | 180 days post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Calcified Coronary Lesions, Coronary Arterial Stenosis