Disrupt CAD III With the Shockwave Coronary IVL System
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
1 other identifier
interventional
431
4 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Jan 2019
Typical duration for not_applicable coronary-artery-disease
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2018
CompletedFirst Posted
Study publicly available on registry
July 23, 2018
CompletedStudy Start
First participant enrolled
January 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2020
CompletedResults Posted
Study results publicly available
June 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2022
CompletedMay 19, 2023
May 1, 2023
1.3 years
June 22, 2018
March 5, 2021
May 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure
The primary safety endpoint was freedom from 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.
within 30 days of index procedure
Number of Participants With Procedural Success (Residual Stenosis <50%)
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. The primary endpoints were analyzed using the Pivotal Analysis Set.
12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
Secondary Outcomes (68)
Number of Participants With Device Crossing Success
at end of procedure
Number of Participants With Angiographic Success (Residual Stenosis <50%)
at end of procedure
Number of Participants With Procedural Success (Residual Stenosis <=30%)
12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
Number of Participants With Angiographic Success (Residual Stenosis <=30%)
at end of procedure
Number of Participants With Serious Angiographic Complications
at end of procedure
- +63 more secondary outcomes
Study Arms (1)
Coronary Lithotripsy System
EXPERIMENTALAll subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System
Interventions
Deliver Lithotripsy to the target vessel prior to placing a coronary stent.
Eligibility Criteria
You may qualify if:
- Subject is ≥18 years of age
- Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
- 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).
- 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.
- 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).
- 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).
- 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)
- 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:
- \>30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
- \>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
- \>30 days after the study procedure
- 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
- +6 more criteria
You may not qualify if:
- 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 (for patients not on oral anticoagulation)
- 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 greater than or equal to 10%
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Honor Health
Scottsdale, Arizona, 85258, United States
Scripps Clinic
La Jolla, California, 92037, United States
University of California, San Diego (UCSD) - Medical Center
La Jolla, California, 92037, United States
St. Joseph Hospital
Orange, California, 92868, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Yale New Haven Hospital
New Haven, Connecticut, 06520, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Northwestern University
Chicago, Illinois, 60611, United States
Advocate Health and Hospitals Corporation - Edward Hospital
Oakbrook Terrace, Illinois, 60540, United States
St. Vincent Heart Center of Indiana, LLC
Indianapolis, Indiana, 46290, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015, United States
New York University (NYU) Langone Medical Center
New York, New York, 10016, United States
Columbia University Medical Center/ New York Presbyterian
New York, New York, 10065, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Durham VA Health Care System
Durham, North Carolina, 27705, United States
NC Heart and Vascular
Raleigh, North Carolina, 27607, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19096, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Pinnacle Health Cardiovascular Institute Inc.
Wormleysburg, Pennsylvania, 17043, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Vermont
Burlington, Vermont, 05401, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Charleston Area Medical Center (CAMC) - Health Education & Research Institute
Charleston, West Virginia, 25304, United States
Clinique Pasteur
Toulouse, Cedex 3, 31076, France
Clinique des Domes - Pole Sante Republique
Clermont-Ferrand, 63050, France
Institute Cardiovasculaire Paris Sud
Massy, 91300, France
Universitaetsklinikum Giessen and Marburg GmbH
Marburg, CET, Germany
Charité - Universitaetsmedizin Berlin
Berlin, 12203, Germany
Rheinland Klinikum Neuss GmbH - Lukaskrankenhaus Neuss
Neuss, 41464, Germany
Golden Jubilee National Hospital
Clydebank, G81 4DY, United Kingdom
St. Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Related Publications (3)
Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15.
PMID: 33069849RESULTKereiakes DJ, Hill JM, Ben-Yehuda O, Maehara A, Alexander B, Stone GW. Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial. Am Heart J. 2020 Jul;225:10-18. doi: 10.1016/j.ahj.2020.04.005. Epub 2020 Apr 18.
PMID: 32470635RESULTKereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.
PMID: 33939604DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Randee Randoll
- Organization
- Shockwave Medical
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2018
First Posted
July 23, 2018
Study Start
January 9, 2019
Primary Completion
May 7, 2020
Study Completion
April 10, 2022
Last Updated
May 19, 2023
Results First Posted
June 21, 2021
Record last verified: 2023-05