The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary IVL Catheter for the treatment of calcified, stenotic de novo coronary artery lesions prior to stenting.
The Shockwave Javelin Coronary IVL Catheter was developed to address the current challenges clinicians face when treating tight, difficult to cross, calcified coronary lesions and was designed as a rapid exchange catheter to deliver intravascular lithotripsy to those complex lesions in the coronary vasculature. The intended benefit of the Shockwave Javelin Coronary IVL Catheter is to allow the catheter to modify calcium in tight, difficult to cross lesions to increase the compliance of the vessel and allow further crossing of the device or additional treatment at the discretion of the physician. Up to 158 subjects (150 evaluable) subjects with moderate-to severely calcified, stenotic de novo coronary artery lesions presenting with stable angina or following stabilization after acute coronary syndrome (ACS) that are suitable for non-emergent percutaneous coronary intervention (PCI) will be enrolled at up to 35 sites. Once the pivotal cohort is fully enrolled (N=158), the study will continue to enroll an Extended Investigation cohort of up to 250 additional subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
408
The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Coronary Catheter is intended to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to balloon crossing, full dilatation or subsequent uniform coronary stent expansion.
Primary Safety Endpoint - Freedom from MACE within 30 days
Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure. MACE (Clinical Events Committee \[CEC\] adjudicated) is defined as: * Cardiac death; or * Myocardial infarction (MI) defined as CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave at discharge (periprocedural MI) and using the Fourth Universal Definition of Myocardial Infarction beyond discharge (spontaneous MI); or * Target vessel revascularization (TVR) defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
Time frame: 30 Days
Primary Performance Endpoint - Technical Success
Technical Success defined as successful Shockwave Javelin Coronary IVL-enabled lesion crossing without serious angiographic complications determined by angiographic core lab
Time frame: Peri-procedural
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Scripps Health
La Jolla, California, United States
ACTIVE_NOT_RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
ACTIVE_NOT_RECRUITINGSouth Denver Cardiology Associates, P.C
Littleton, Colorado, United States
ACTIVE_NOT_RECRUITINGHartford Hospital
Hartford, Connecticut, United States
ACTIVE_NOT_RECRUITINGMedstar Washington Hospital Center
Washington D.C., District of Columbia, United States
ACTIVE_NOT_RECRUITINGThe Cardiac and Vascular Institute
Gainesville, Florida, United States
ACTIVE_NOT_RECRUITINGPiedmont Heart Institute
Atlanta, Georgia, United States
ACTIVE_NOT_RECRUITINGEmory University Hospital
Atlanta, Georgia, United States
ACTIVE_NOT_RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
ACTIVE_NOT_RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
ACTIVE_NOT_RECRUITING...and 24 more locations