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Trial record 1 of 1 for:    NCT03595176
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Disrupt CAD III With the Shockwave Coronary IVL System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03595176
Recruitment Status : Active, not recruiting
First Posted : July 23, 2018
Results First Posted : June 21, 2021
Last Update Posted : June 21, 2021
Information provided by (Responsible Party):
Shockwave Medical, Inc.

Brief Summary:
The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Infarction Device: Lithotripsy Not Applicable

Detailed Description:
Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI). Approximately 392 subjects at 50 sites will be enrolled. A minimum of 50% of the total enrollment will come from the United States.Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 431 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The Coronary IVL System is a proprietary balloon catheter system designed to enhance stent outcomes by enabling delivery of the calcium disrupting capability of lithotripsy prior to balloon dilatation at low pressures. The Coronary IVL System consists of an IVL Balloon Catheter with two integrated pairs of lithotripsy emitters, a Lithotripsy Generator, and Connector Cable.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries
Actual Study Start Date : January 9, 2019
Actual Primary Completion Date : May 7, 2020
Estimated Study Completion Date : April 2022

Arm Intervention/treatment
Experimental: Coronary Lithotripsy System
All subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System
Device: Lithotripsy
Deliver Lithotripsy to the target vessel prior to placing a coronary stent.

Primary Outcome Measures :
  1. Number of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure [ Time Frame: within 30 days of index procedure ]
    The primary safety endpoint was freedom from major adverse cardiac events (MACE) at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Pivotal Analysis Set.

  2. Number of Participants With Procedural Success [ Time Frame: at discharge ]
    The primary effectiveness endpoint was Procedural Success defined as stent delivery with a residual in-stent stenosis <50% (core laboratory assessed) and without in-hospital MACE.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject is ≥18 years of age
  2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
  3. For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure (note: if both labs are drawn, both must be normal).
  4. For patients with stable ischemic heart disease, biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath.

    1. If drawn prior to the procedure, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours of the procedure (note: if both labs are drawn, both must be normal).
    2. If biomarkers are drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analyzed prior to enrollment (note: CK-MB is required if drawn from the sheath).
  5. Left ventricular ejection fraction >25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criteria; 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. 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 with no post-procedure biomarker elevation >normal; or
    3. >30 days after the study procedure

    Angiographic Inclusion Criteria

  8. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
  9. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with:

    1. Stenosis of ≥70% and <100% or
    2. Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
  10. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
  11. The lesion length must not exceed 40 mm
  12. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre- dilatation)
  13. Evidence of calcification at the lesion site by, a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section
  14. Ability to pass a 0.014" guide wire across the lesion

Exclusion Criteria:

  1. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
  2. Subject is a member of a vulnerable population as defined in 21 CFR 56.111, including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention
  3. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
  4. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
  5. Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months (for patients not on oral anticoagulation)
  6. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
  7. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK-MB greater than 1 times the local laboratory's upper limit of normal
  8. New York Heart Association (NYHA) class III or IV heart failure
  9. Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
  10. History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit
  11. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
  12. Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
  13. 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)
  14. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders
  15. Uncontrolled diabetes defined as a HbA1c greater than or equal to 10%
  16. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
  17. Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia)
  18. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
  19. Subjects with a life expectancy of less than 1 year
  20. 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
  21. 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
  22. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
  23. Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
  24. High SYNTAX Score (≥33) if assessed as standard of care, unless the local heart team has met and recommends PCI is the most appropriate treatment for the patient
  25. Unprotected left main diameter stenosis >30%
  26. Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º
  27. Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
  28. Evidence of aneurysm in target vessel within 10 mm of the target lesion
  29. Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion
  30. Target lesion is a bifurcation with ostial diameter stenosis ≥30%
  31. Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches
  32. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
  33. Previous stent within the target vessel implanted within the last year
  34. Previous stent within 10 mm of the target lesion regardless of the timing of its implantation
  35. Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03595176

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Sponsors and Collaborators
Shockwave Medical, Inc.
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Study Chair: Dean J Kereiakes, MD,FACC,FSCAI The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
Study Chair: Gregg W Stone, MD,FACC,FSCAI Columbia University
Study Chair: Jonathan Hill, MD Royal Brompton and Harefield NHS Foundation Trust
  Study Documents (Full-Text)

Documents provided by Shockwave Medical, Inc.:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Shockwave Medical, Inc. Identifier: NCT03595176    
Other Study ID Numbers: CP 61982
First Posted: July 23, 2018    Key Record Dates
Results First Posted: June 21, 2021
Last Update Posted: June 21, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Shockwave Medical, Inc.:
Intravascular Lithotripsy
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases