FORWARD CAD IDE Study for Coronary Artery Disease
This study is testing a new device called the Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary Catheter. This device uses sound waves to treat hardened, calcified blockages in your heart arteries (coronary artery disease) before a stent is placed. The goal is to make it easier to place a stent and improve blood flow. You might be able to join if you are 18 or older and have stable angina (chest pain) or have recently stabilized after a heart attack, and have calcified blockages suitable for a non-emergency procedure. The study will look at how safe the device is within 30 days and if it successfully treats the blockage during the procedure. The current recruitment status is unclear, but the study plans to enroll 408 participants.
- Study design
- This is a single-arm study, meaning all participants receive the investigational device. It plans to enroll up to 408 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety outcomes for 30 days after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
FORWARD CAD IDE Study
At a glance
Conditions
Where it's being run
34 sites across 18 statesStudy leadership
- Robert W Yeh, M.D., M.Sc, M.B.A · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center
- James C Spratt, MD, MB, ChB, FRCP, FESC, FACC · PRINCIPAL_INVESTIGATOR · St. George's University NHS Trust
- Robert F Riley, MD, MS, FACC, FAHA, FSCAI · PRINCIPAL_INVESTIGATOR · Overlake Medical Center & Clinics
Who to contact
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What this trial measures
- Primary Safety Endpoint - Freedom from MACE within 30 days30 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
- Primary Performance Endpoint - Technical SuccessPeri-procedural
Technical Success defined as successful Shockwave Javelin Coronary IVL-enabled lesion crossing without serious angiographic complications determined by angiographic core lab