FORWARD CAD IDE Study
ConditionCoronary Arterial Disease (CAD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShockwave Medical, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is ≥18 years of age
Subject is able and willing to comply with all assessments in the study.
Subjects with native coronary artery disease including stable angina or following stabilization after acute coronary syndromes (ACS) for non-emergent percutaneous coronary intervention (PCI)
less than or equal to the upper limit of lab normal within 24 hours prior to the procedure or may be drawn from the side port of the sheath at the time of index if the PCI is a non-emergent procedure and has stable angina (result will not be known prior to procedure); OR
Disqualifiers
Any comorbidity or condition which may prevent compliance with this protocol, including follow-up visits
Subject is participating in another research study involving an investigational agent including pharmaceutical, biologic, or medical device that has not reached the primary endpoint
Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines
Trial design
Design model
Single group
Treatments tested in this trial
Intravascular Lithotripsy
DeviceThe 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.
Treatment groups
408 Participants
are divided into 1 treatment groupGroup A: Shockwave Javelin Coronary IVL CatheterExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 Days2
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-proceduralSponsors and contacts
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Source ClinicalTrials.gov