Working... Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03595176
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : May 10, 2019
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.

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.

Layout table for study information
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; 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject is ≥ 18 years of age
  • Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for percutaneous coronary intervention (PCI)
  • Troponin or CK-MB must be less than or equal to the upper limit of lab normal value within 12 hrs prior to the procedure.
  • Left ventricular ejection fraction >25% within 6 months
  • The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
  • Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with: Stenosis of ≥ 70% and <100% or Stenosis ≥50% and <70% (visually assessed) with evidence of clinical ischemia via positive stress test, or fractional flow reserve value ≤0.8, or iFR <0.90 or IVUS or OCT minimum lumen area≤4.0 mm²
  • The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
  • The lesion length must not exceed 40 mm
  • The target vessel must have TIMI flow 3 at baseline (visually assessed) -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
  • Ability to pass a 0.014" guide wire across the lesion
  • Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
  • 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

Exclusion Criteria:

  • Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
  • 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
  • Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
  • Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
  • Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months
  • Subject has an allergy to imaging contrast media which cannot be adequately pre- medicated
  • 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)
  • New York Heart Association (NYHA) class III or IV heart failure
  • Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
  • History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
  • Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
  • 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)
  • Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders
  • Uncontrolled diabetes defined as a HbA1c equal or greater than 10%
  • Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
  • Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia)
  • Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg
  • Subjects with a life expectancy of less than 1 year
  • 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
  • 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
  • Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
  • Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
  • 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
  • Unprotected left main diameter stenosis >30%
  • Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º
  • Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
  • Evidence of aneurysm in target vessel within 10 mm of the target lesion
  • Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion
  • Target lesion is a bifurcation with ostial diameter stenosis ≥30%
  • Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches
  • Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
  • Previous stent within the target vessel implanted within the last year
  • Previous stent within 10 mm of the target lesion regardless of the timing of its implantation
  • 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

Layout table for location contacts
Contact: Lahn Fendelander 510.279.4262

Layout table for location information
United States, California
Scripps Clinic Recruiting
La Jolla, California, United States, 92037
Contact: Janet Daniel    858-824-5238   
Principal Investigator: Matthew Price, MD         
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Judy Baer    650-493-5000 ext 67142   
Principal Investigator: Celina Yong, MD         
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Shreejana Pokharel    201-877-7066   
Principal Investigator: Ron Waksman, MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Akimi Rhodes    404-605-2371   
Principal Investigator: Andrew Klein, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Amy Carswell   
Principal Investigator: Mark Ricciardi, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jenifer M Kaufman    617-632-8956   
Principal Investigator: Robert Yeh, MD         
United States, Mississippi
North Mississippi Medical Center Recruiting
Tupelo, Mississippi, United States, 38801
Contact: Amber Schmitz    662-377-7572   
Principal Investigator: Barry Bertolet, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Cornelia Rivera    646-477-7506   
Principal Investigator: Giora Weisz, MD         
Columbia University Medical Center/ New York Presbyterian Recruiting
New York, New York, United States, 10065
Contact: Candido Batres    212-342-3486   
Principal Investigator: Jeffrey Moses, MD         
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Lyn Santiago    515-562-6763   
Principal Investigator: Richard Shlofmitz, MD         
United States, North Carolina
NC Heart and Vascular Recruiting
Raleigh, North Carolina, United States, 27607
Contact: James Pierre-Louis    919-784-7695   
Principal Investigator: James Zidar, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Roxanne Robertson    513-585-1777   
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   
Principal Investigator: Jason Wollmuth, MD         
United States, Pennsylvania
Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19096
Contact: Lynn Sher    484-337-4386   
Principal Investigator: Sarang Mangalmurti, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sasha Naidu    215-662-6590   
Principal Investigator: Herrmann Howard, MD         
Pinnacle Health Cardiovascular Institute Inc. Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Gretchen Meise    717-920-4400 ext 4280   
Principal Investigator: William Bachinsky, MD         
United States, Texas
Baylor Heart and Vascular Hospital Recruiting
Dallas, Texas, United States, 75226
Contact: Geoffrey Gong, MD    214-820-9903   
Principal Investigator: Robert Stoler, MD         
Sponsors and Collaborators
Shockwave Medical, Inc.
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Shockwave Medical, Inc. Identifier: NCT03595176     History of Changes
Other Study ID Numbers: CP 61982
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

Layout table for additional information
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:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases