Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
158 participants
INTERVENTIONAL
2025-04-04
2028-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Shockwave Javelin Coronary IVL Catheter
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).
Intravascular Lithotripsy
The 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.
Interventions
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Intravascular Lithotripsy
The 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.
Eligibility Criteria
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Inclusion Criteria
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
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)
Exclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert W Yeh, M.D., M.Sc, M.B.A
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
James C Spratt, MD, MB, ChB, FRCP, FESC, FACC
Role: PRINCIPAL_INVESTIGATOR
St. George's University NHS Trust
Robert F Riley, MD, MS, FACC, FAHA, FSCAI
Role: PRINCIPAL_INVESTIGATOR
Overlake Medical Center & Clinics
Locations
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Scripps Health
La Jolla, California, United States
University of California, San Francisco
San Francisco, California, United States
South Denver Cardiology Associates, P.C
Littleton, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
The Cardiac and Vascular Institute
Gainesville, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
NYU Langone Health
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
St. Francis Hospital & Heart Center
Roslyn, New York, United States
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Providence St. Vincent
Portland, Oregon, United States
Wellspan York Hospital
York, Pennsylvania, United States
Centennial Heart
Nashville, Tennessee, United States
Baylor Scott & White Research Institute Dallas
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Baylor Scott and White - The Heart Hospital Baylor Plano
Plano, Texas, United States
Intermountain Medical Center Heart Institute
Salt Lake City, Utah, United States
Overlake Medical Center
Bellevue, Washington, United States
Swedish Medical
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Basildon University Hospital
Basildon, UK, United Kingdom
Bristol Heart Institute
Bristol, UK, United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds, UK, United Kingdom
Glenfield Hospital
Leicester, UK, United Kingdom
St. Thomas Hospital
London, UK, United Kingdom
St. George's Hospital
London, UK, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Brendan Neilan
Role: primary
Kaye Reambonanza
Role: primary
Rachel Kim
Role: primary
Marianne McCarthy
Role: primary
Michelle Singh
Role: primary
Marti Roberson
Role: primary
Suzanne Corley
Role: primary
Mutsa Seremwe
Role: primary
Sidney Searles
Role: primary
Barbora Zvarova
Role: primary
Jenifer Kaufman
Role: primary
Opeyemi Akindumila
Role: primary
Natalie Massenburg
Role: primary
Kate Dalton, MS, RD, CCRC
Role: primary
Sara Velichkovikj
Role: primary
Elizabeth Haag
Role: primary
James Pierre-Louis
Role: primary
Kiera Carlisle
Role: primary
Sheryl Ames
Role: primary
Lori Slenker
Role: primary
Sean O'Malley
Role: primary
Geoffrey Gong
Role: primary
Padmaja Naik
Role: primary
Selena Ortega
Role: primary
Michael Tomlinson
Role: primary
Gowri Rajendran
Role: primary
Tina Pratt
Role: primary
John Tushinski
Role: primary
Kelly Musson
Role: primary
Marissa Kearns
Role: primary
Dean Waugh
Role: primary
Judith Fisher
Role: primary
Emma Perchard
Role: primary
Sophie Horne
Role: primary
Other Identifiers
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CP 71886
Identifier Type: -
Identifier Source: org_study_id