Shockwave therapy could crack tough heart blockages

NCT ID NCT06662500

Disease control Sponsor: Shockwave Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests a new device that uses sound waves to break up calcium deposits in heart arteries before placing a stent. About 408 adults with coronary artery disease will receive this treatment. The goal is to see if the device is safe and effective at clearing blockages to improve blood flow.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 408 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

General Inclusion Criteria: 1. Subject is ≥18 years of age 2. Subject is able and willing to comply with all assessments in the study. 3. Subjects with native coronary artery disease including stable angina or following stabilization after acute coronary syndromes (ACS) for non-emergent percutaneous coronary intervention (PCI) 4. Biomarkers (troponin) must be: 1. 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 2. if above the upper limit of lab normal, biomarker result must be less than 5 times the upper limit of lab normal within 24 hours prior to the procedure and the following criteria must be met: • The procedure must not be emergent and the subject cannot have angina at rest. 5. Left ventricular ejection fraction (LVEF) \>30% within 6 months (note: in the case of an event (MI or Revascularization) the LVEF must be taken post-event and in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criterion; may be assessed at time of index procedure). 6. Subject, or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures. 7. Estimated life expectancy \>1 year. 8. Lesions in non-target vessels requiring PCI may be treated either: 1. \>30 days prior to the study procedure if the procedure was unsuccessful or complicated; OR 2. \>24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis \<30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and no evidence of elevated biomarkers post-procedure; OR 3. \>30 days after the study procedure Angiographic Inclusion Criteria 9. The target lesion must be a de novo coronary lesion that has not been previously treated successfully with any interventional procedure 10. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) 11. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm 12. The target lesion must meet one of the following criteria: 1. Target lesion stenosis \>90% up to 40 mm in length and evidence of moderate or severe calcification at the lesion site. Moderate calcification defined as angiography with densities noted only during the cardiac cycle prior to contrast injection; severe calcification defined as angiography with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall; OR 2. Chronic total occlusion presenting with J-CTO score of 1 with evidence of calcification and occlusion length up to 20 mm. 13. Guidewire must be in true lumen, distal to the lesion, and not subintimal, prior to insertion of Shockwave Javelin Coronary IVL catheter (antegrade wire technique only) General Exclusion Criteria: 1. Any comorbidity or condition which may prevent compliance with this protocol, including follow-up visits 2. Subject is participating in another research study involving an investigational agent including pharmaceutical, biologic, or medical device that has not reached the primary endpoint 3. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment) 4. Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines 5. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated 6. Subject experienced an acute STEMI within 30 days prior to index procedure 7. New York Heart Association (NYHA) class III or IV heart failure 8. Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73m2 (using institutional formula) 9. History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit 10. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months 11. Untreated pre-procedural hemoglobin \<10 g/dL or intention to refuse blood transfusions if one should become necessary 12. Coagulopathy, including but not limited to platelet count \<100,000 or International Normalized ratio (INR) \>1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment) 13. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count \>750,000 or other disorders 14. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics 15. Subjects with clinical evidence of cardiogenic shock 16. Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg) 17. Subjects with an estimated life expectancy of less than 1 year 18. Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure 19. Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure 20. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery 21. Planned use of atherectomy, scoring or cutting balloon, sub-intimal reentry device, or any investigational device other than coronary IVL Angiographic Exclusion Criteria 22. Unprotected left main diameter stenosis \>30% 23. Evidence of a serious angiographic complication in the target vessel prior to treatment with coronary IVL (dissection, perforation, abrupt closure, persistent slow-flow or persistent no reflow) 24. Definite or possible thrombus by angiography in the target vessel 25. Evidence of aneurysm in target vessel within 10 mm of the target lesion 26. Second lesion with \>50% stenosis in the same target vessel as the target lesion including its side branches 27. Chronic total occlusion of the target lesion, J-CTO ≥2 28. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft 29. Previous stent within 5 mm of the target lesion 30. Failure to successfully cross the guidewire across the target lesion 31. Planned use of antegrade dissection and reentry (ADR), retrograde guidewire (RW), or retrograde dissection and reentry (RDR) crossing technique at any time during the procedure.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary arterial disease (CAD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

34 sites in 2 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Basildon University Hospital
RECRUITING

Basildon, UK, SS16 5NL, United Kingdom
Baylor Scott & White Research Institute Dallas
RECRUITING

Dallas, Texas, 75226, United States
Baylor Scott and White - The Heart Hospital Baylor Plano
RECRUITING

Plano, Texas, 75093, United States
Beth Israel Deaconess Medical Center
RECRUITING

Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Bristol Heart Institute
RECRUITING

Bristol, UK, BS2 8ED, United Kingdom
Centennial Heart
RECRUITING

Nashville, Tennessee, 37203, United States
Columbia University Medical Center/New York Presbyterian Hospital
RECRUITING

New York, New York, 10032, United States
Emory University Hospital
RECRUITING

Atlanta, Georgia, 30322, United States
Glenfield Hospital
RECRUITING

Leicester, UK, LE3 9QP, United Kingdom
Hartford Hospital
RECRUITING

Hartford, Connecticut, 06112, United States
Houston Methodist Hospital
RECRUITING

Houston, Texas, 77030, United States
Intermountain Medical Center Heart Institute
RECRUITING

Salt Lake City, Utah, 84111, United States
Leeds Teaching Hospital NHS Trust
RECRUITING

Leeds, UK, LS1 3EX, United Kingdom
Lenox Hill Hospital
RECRUITING

New York, New York, 10075, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Medstar Washington Hospital Center
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Minneapolis Heart Institute
RECRUITING

Minneapolis, Minnesota, 55407, United States
NC Heart and Vascular Research, LLC
RECRUITING

Raleigh, North Carolina, 27607, United States
NYU Langone Health
RECRUITING

New York, New York, 10016, United States
Overlake Medical Center
RECRUITING

Bellevue, Washington, 98004, United States
Piedmont Heart Institute
RECRUITING

Atlanta, Georgia, 30309, United States
Providence St. Vincent
RECRUITING

Portland, Oregon, 97225, United States
Scripps Health
RECRUITING

La Jolla, California, 92037, United States
South Denver Cardiology Associates, P.C
RECRUITING

Littleton, Colorado, 80120, United States
St. Francis Hospital & Heart Center
RECRUITING

Roslyn, New York, 11576, United States
St. George's Hospital
RECRUITING

London, UK, SW17 0RE, United Kingdom
St. Thomas Hospital
RECRUITING

London, UK, SE1 7EH, United Kingdom
Swedish Medical
RECRUITING

Seattle, Washington, 98122, United States
The Cardiac and Vascular Institute
RECRUITING

Gainesville, Florida, 32605, United States
The Christ Hospital
RECRUITING

Cincinnati, Ohio, 45219, United States
University of California, San Francisco
RECRUITING

San Francisco, California, 94143, United States
University of Washington Medical Center
RECRUITING

Seattle, Washington, 98195, United States
Wellspan York Hospital
RECRUITING

York, Pennsylvania, 17403, United States

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