Coronary Arterial Disease (CAD)

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.

FORWARD CAD IDE Study

Coronary Artery Disease (CAD)

Coronary Artery Disease

Heart Conditions

Heart and lung conditions

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.

Intravascular Lithotripsy

Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study of the Shockwave Intravascular Lithotripsy (IVL) System With the Shockwave Javelin Coronary IVL Catheter (FORWARD CAD IDE Study)

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

Technical Success defined as successful Shockwave Javelin Coronary IVL-enabled lesion crossing without serious angiographic complications determined by angiographic core lab

The Shockwave Javelin Coronary IVL Catheter will be used to treat 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).

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 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.

Scripps Health

South Denver Cardiology Associates, P.C

Hartford Hospital

Medstar Washington Hospital Center

The Cardiac and Vascular Institute

Emory University Hospital

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

NYU Langone Health

Columbia University Medical Center/New York Presbyterian Hospital

St. Francis Hospital & Heart Center

NC Heart and Vascular Research, LLC

The Christ Hospital

Wellspan York Hospital

Centennial Heart

Baylor Scott & White Research Institute Dallas

Baylor Scott and White - The Heart Hospital Baylor Plano

Overlake Medical Center

Swedish Medical

Basildon University Hospital

Bristol Heart Institute

Leeds Teaching Hospital NHS Trust

Glenfield Hospital

St. George's Hospital

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

Technical Success defined as successful Shockwave Javelin Coronary IVL-enabled lesion
crossing without serious angiographic complications determined by angiographic core lab

The Shockwave Javelin Coronary IVL Catheter will be used to treat 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).

FORWARD CAD IDE Study

Trials at a glance

Trials at a glance

FORWARD CAD IDE Study

Outcome measures

Primary outcome measures