Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)

Not Applicable

Completed

Conditions: Coronary Artery Disease

Interventions: Device: Shockwave Coronary Rx Lithoplasty® System

Registration Number: NCT02650128

Lead Sponsor: Shockwave Medical, Inc.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lithoplasty System	Shockwave Coronary Rx Lithoplasty® System	Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement

Primary Outcome Measures

Name	Time	Method
Safety - Frequency of Major Adverse Cardiac Events (MACE) Within 30 Days of the Procedure.	30 days	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
Performance	Post-procedure (within 24 hours following procedure and prior to discharge)	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.

Secondary Outcome Measures

Name	Time	Method
Quantitative Assessment of the Residual Stenosis in Treated Lesions	Post-procedure (within 24 hours following procedure and prior to discharge)	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
180 Day MACE	180 days post-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

Trial Locations

Locations (7): Monash Heart, Monash Health
🇦🇺
Clayton, Victoria, Australia
Skane University Hospital- Lund
🇸🇪
Lund, Sweden
Clinic Pastuer
🇫🇷
Toulouse, France
Thoraxcenter, Erasmus MC
🇳🇱
Rotterdam, Netherlands
King's College Hospital
🇬🇧
London, United Kingdom
St. Vincent's Hospital
🇦🇺
Melbourne, Victoria, Australia
Royal Brompton Hospital
🇬🇧
London, United Kingdom