What is the Shockwave Javelin Coronary IVL Catheter studying for coronary artery disease?

The study is evaluating the safety and technical success of the Shockwave Javelin Coronary IVL Catheter to treat calcified coronary artery lesions before stenting. Researchers aim to see if this device can effectively improve vessel compliance and allow better treatment of these complex lesions. The study is sponsored by Shockwave Medical, Inc.

Who may be eligible for this coronary artery disease clinical trial?

Adults 18 years or older with native coronary artery disease and moderate to severe calcified lesions suitable for non-emergent PCI may qualify. Participants must have stable angina or be stabilized after acute coronary syndrome, with a left ventricular ejection fraction above 30%. Please review eligibility criteria for more details.

Is there any cost to participate in this coronary artery disease clinical trial?

Study-related care, including the investigational device and all trial visits, is provided at no cost. However, personal travel and other expenses are not guaranteed to be covered and may vary.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06662500

Study of the Shockwave Javelin Coronary IVL Catheter to Treat Calcified Narrowing in Coronary Arteries Before Stenting

Led by Shockwave Medical, Inc. · Updated on 2026-08-03

408

Participants Needed

Research Sites

103 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the Shockwave Intravascular Lithotripsy IVL System with the Shockwave Javelin Coronary IVL Catheter to treat calcified, narrowed coronary artery lesions before stenting. This prospective, multicenter, single-arm investigational device exemption study aims to assess the safety and performance of this device in patients with moderate to severely calcified coronary artery disease, including those with stable angina or after stabilization from acute coronary syndrome. The study uses the Shockwave Javelin Coronary IVL Catheter, designed to deliver intravascular lithotripsy to modify calcium in tight, difficult-to-cross lesions. This treatment aims to increase vessel compliance, allowing better device crossing and additional therapies as needed. Up to 158 subjects will be enrolled initially, followed by an extended cohort of up to 250 additional participants, all undergoing non-emergent percutaneous coronary intervention using the device. Participants will be monitored with assessments including freedom from major cardiac events within 30 days and technical success of the procedure during the intervention. The study involves screening, treatment with the investigational device, and follow-up visits to evaluate safety and effectiveness. Researchers will collect clinical data including biomarkers, heart function measurements, and angiographic imaging to assess outcomes throughout the study period.

CONDITIONS

Brief Title

FORWARD CAD IDE Study

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

18 years of age or older
Able and willing to comply with all study assessments
Native coronary artery disease with stable angina or stabilized after acute coronary syndrome suitable for non-emergent PCI
Biomarkers (troponin) within lab normal limits or meeting specific criteria within 24 hours prior to procedure
Left ventricular ejection fraction greater than 30% within 6 months
Signed informed consent prior to any study procedures
Estimated life expectancy greater than 1 year
Lesions in non-target vessels may be treated either >30 days prior, >24 hours prior if successful, or >30 days after the study procedure
Target lesion is a de novo coronary lesion not previously treated
Single de novo target lesion stenosis in protected LMCA, LAD, RCA, LCX, or branches
Target vessel reference diameter between 2.5 mm and 4.0 mm
Target lesion stenosis >90% up to 40 mm length with moderate or severe calcification, or chronic total occlusion with J-CTO score 1 and calcification up to 20 mm
Guidewire must be in true lumen distal to lesion before catheter insertion

You will not qualify if you...

Any comorbidity or condition preventing protocol compliance including follow-up visits
Participation in another investigational study not completed
Pregnant or nursing women
Unable to tolerate antiplatelet or anticoagulation therapy per guidelines
Allergy to imaging contrast media not manageable by pre-medication
Acute STEMI within 30 days before procedure
NYHA class III or IV heart failure
Acute or chronic renal disease with eGFR <30 ml/min/1.73m2
Stroke or transient ischemic attack within 60 days or prior intracranial hemorrhage or permanent neurological deficit
Active peptic ulcer or upper GI bleeding within 3 months
Untreated pre-procedural hemoglobin <10 g/dL or refusal of transfusions
Coagulopathy including platelet count <100,000 or INR >1.7 if on warfarin
Hypercoagulable disorders such as polycythemia vera or platelet count >750,000
Active systemic infection on day of procedure
Clinical evidence of cardiogenic shock
Uncontrolled severe hypertension (systolic >180 mm Hg or diastolic >110 mm Hg)
Estimated life expectancy less than 1 year
Non-coronary structural heart procedures within 30 days before or planned within 30 days after procedure
Refusal or contraindication for emergency coronary artery bypass grafting
Planned use of certain devices or techniques other than coronary IVL
Unprotected left main diameter stenosis >30%
Serious angiographic complications prior to treatment
Definite or possible thrombus in target vessel
Aneurysm near target lesion
Second lesion with >50% stenosis in same vessel
Chronic total occlusion with J-CTO score ≥2
Target lesion only reachable via bypass graft
Previous stent within 5 mm of target lesion
Failure to cross guidewire across target lesion
Planned use of specific crossing techniques during procedure

Research Team

Randee Randoll

Lesli DeSimone

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Study of the Shockwave Javelin Coronary IVL Catheter to Treat Calcified Narrowing in Coronary Arteries Before Stenting

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria