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Disrupt CAD III With the Shockwave Coronary IVL System

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ClinicalTrials.gov Identifier: NCT03595176
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : October 9, 2019
Sponsor:
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)
Estimated Enrollment : 392 participants
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
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : July 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. No. of participants with treatment and device related adverse events. Adverse Events must meet definition of (MACE) Major Adverse Cardiac Events [ Time Frame: within 30 days of index procedure ]

    Definition of MACE:

    • 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

  2. No. of participants that had a successful index procedure and without in-hospital MACE [ Time Frame: at the end of the procedure ]
    Successful procedure is defined as delivering lithotripsy to the target vessel and placing a coronary stent with residual stenosis of less than 50% (Core lab assessed) and without in-hospital MACE. MACE definition is defined in outcome 1



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

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 ClinicalTrials.gov identifier (NCT number): NCT03595176


Contacts
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Contact: Lahn Fendelander 510.279.4262 lfendelander@shockwavemedical.com

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Locations
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United States, Arizona
Honor Health Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joanne Saczynski    480-323-3390    joanne.saczynski@honorhealth.com   
Principal Investigator: David Rizik, MD         
United States, California
Scripps Clinic Recruiting
La Jolla, California, United States, 92037
Contact: Janet Daniel    858-824-5238    daniel.janet@scrippshealth.org   
Principal Investigator: Matthew Price, MD         
St. Joseph Hospital Recruiting
Orange, California, United States, 92868
Contact: Sandy Chung    714-744-8795    sandy.chung@stjoe.org   
Principal Investigator: Brian Kolski, MD         
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Judy Baer    650-493-5000 ext 67142    judy.baer@va.gov   
Principal Investigator: Celina Yong, MD         
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Jackie Gamberdella    203-737-1899    jacqueline.gamberdella@yale.edu   
Principal Investigator: Carlos Mena-Hurtado, MD         
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Shreejana Pokharel    201-877-7066    shreejana.pokharel@medstar.net   
Principal Investigator: Ron Waksman, MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Akimi Rhodes    404-605-2371    akimi.rhodes@piedmont.org   
Principal Investigator: Andrew Klein, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Amy Carswell       amy.carswell@nm.org   
Principal Investigator: Mark Ricciardi, MD         
United States, Indiana
St. Vincent Heart Center of Indiana, LLC Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Rachel Johnson    317-586-6303    rachel.johnson6@ascension.org   
Principal Investigator: Michael Kourany, MD         
United States, Maryland
MedStar Union Memorial Hospital Recruiting
Baltimore, Maryland, United States, 21218
Contact: Mary Park    443-278-9170 ext 3    mary.b.park@medstar.net   
Principal Investigator: John Wang, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jenifer M Kaufman    617-632-8956    jmkaufma@bidmc.harvard.edu   
Principal Investigator: Robert Yeh, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Margaret Fox    313-916-1879    mfox2@hfhs.org   
Principal Investigator: Khaldoon Alaswad, MD         
United States, Minnesota
Minneapolis Heart Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Amy McMeans    612-863-3793    amy.mcmeans@allina.com   
Principal Investigator: Nicholas Burke, MD         
United States, Mississippi
North Mississippi Medical Center Recruiting
Tupelo, Mississippi, United States, 38801
Contact: Amber Schmitz    662-377-7572    anschmitz@nmhs.net   
Principal Investigator: Barry Bertolet, MD         
United States, Missouri
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Jamie Hall       jhall@saint-lukes.org   
Contact: Lisa Lacy       lnewhouse@saint-lukes.org   
Principal Investigator: Steven Laster, MD         
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Linda Dewey    609-893-1200 ext 5023      
Principal Investigator: Daniel Ice, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Cornelia Rivera    646-477-7506    corivera@montefiore.org   
Principal Investigator: Giora Weisz, MD         
New York University (NYU) Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Crystalann Rodriguez    212-263-4016    crystalann.rodriguez@nyulangone.org   
Principal Investigator: Craig Thompson, MD         
Columbia University Medical Center/ New York Presbyterian Recruiting
New York, New York, United States, 10065
Contact: Candido Batres    212-342-3486    cb2269@cumc.columbia.edu   
Principal Investigator: Jeffrey Moses, MD         
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Lyn Santiago    515-562-6763    lyn.santiago@chsli.org   
Principal Investigator: Richard Shlofmitz, MD         
United States, North Carolina
Durham VA Health Care System Recruiting
Durham, North Carolina, United States, 27705
Contact: Joan Royer       joan.royer@va.gov   
Principal Investigator: Sunil Rao, MD         
NC Heart and Vascular Recruiting
Raleigh, North Carolina, United States, 27607
Contact: James Pierre-Louis    919-784-7695    James.Pierre-Louis@unchealth.unc.edu   
Principal Investigator: James Zidar, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Roxanne Robertson    513-585-1777    roxanne.robertson@thechristhospital.com   
Principal Investigator: Robert Riley, MD         
United States, Oregon
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Gretchen Sminkey    503-216-7162    Gretchen.Sminkey@providence.org   
Principal Investigator: Jason Wollmuth, MD         
United States, Pennsylvania
Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19096
Contact: Lynn Sher    484-337-4386    SherL@MLHS.org   
Principal Investigator: Sarang Mangalmurti, MD         
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Paul Berry    570-271-7176    pmberry@geisinger.edu   
Principal Investigator: Gregory Yost, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sasha Naidu    215-662-6590    suveeksha.naidu@uphs.upenn.edu   
Principal Investigator: Herrmann Howard, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jenny Whitehead       whiteheadj5@upmc.edu   
Principal Investigator: Catalin Toma, MD         
Pinnacle Health Cardiovascular Institute Inc. Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Gretchen Meise    717-920-4400 ext 4280    gmeise@pinnaclehealth.org   
Principal Investigator: William Bachinsky, MD         
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Jassira Gomez    401-793-7335    jgomes8@lifespan.org   
Principal Investigator: Peter Soukas, MD         
United States, Texas
Baylor Heart and Vascular Hospital Recruiting
Dallas, Texas, United States, 75226
Contact: Geoffrey Gong, MD    214-820-9903    gang.gong@BSWHealth.org   
Principal Investigator: Robert Stoler, MD         
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Saba Khan    713-441-2116    skhan7@houstonmethodist.org   
Principal Investigator: Alpesh Shah, MD         
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Amy Henderson    802-847-8833    amy.henderson@uvmhealth.org   
Principal Investigator: Rony Lahoud, MD         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Samantha Solis    206-616-3541    ssolis94@cardiology.washington.edu   
Principal Investigator: William Lombardi, MD         
United States, West Virginia
Charleston Area Medical Center (CAMC) - Health Education & Research Institute Recruiting
Charleston, West Virginia, United States, 25304
Contact: Briana Knapp    304-388-9956    briana.knapp@camc.org   
Principal Investigator: Aravinda Nanjundappa, MD         
France
Clinique Pasteur Recruiting
Toulouse, Cedex 3, France, 31076
Contact: Brigitte Jacob    +33-01-69-85-50-89    g.mottin@icps.com.fr   
Principal Investigator: Jean Fajadet, MD         
Clinique des Domes - Pole Sante Republique Recruiting
Clermont-Ferrand, France, 63050
Contact: Nicolas Caillot    +33.(0)6 80 58 56 45    n.caillot@gmail.com   
Principal Investigator: Janusz Lipiecki, MD         
Institute Cardiovasculaire Paris Sud Recruiting
Massy, France, 91300
Contact: Sharanya Logeswaran    +33.(0)1.69.20.98.39    s.logeswaran@icps.com.fr   
Principal Investigator: Thierry Lefevre, MD         
United Kingdom
Golden Jubilee National Hospital Recruiting
Clydebank, United Kingdom, G81 4DY
Contact: Joanne Kelly    +44 (0)141 951 5256    Joanne.Kelly@goldenjubilee.scot.nhs.uk   
Principal Investigator: Keith Oldroyd, MD         
St. Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Contact: Mervyn Andiapen    +44 (0) 20 376 58707    mervyn.andiapen@bartshealth.nhs.uk   
Principal Investigator: Andreas Baumbach, MD         
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Sheetal Patale    0203 299 2374    sheetalpatale@nhs.net   
Principal Investigator: Ian Webb, MD         
Sponsors and Collaborators
Shockwave Medical, Inc.
Investigators
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Principal Investigator: 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
Principal Investigator: Jonathan Hill, MD Kings College Hospital

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Responsible Party: Shockwave Medical, Inc.
ClinicalTrials.gov Identifier: NCT03595176     History of Changes
Other Study ID Numbers: CP 61982
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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
Coronary Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases