- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03328949
Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)
Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be conducted at 15 sites in Europe and up to 120 participants will be followed for 30 days post procedure.
Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1) cardiac related death, 2) heart attack, and 3) intervention to treat the coronary artery that was previously treated at the procedure visit.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aalst, Belgium
- Onze-Lieve-Vrouwziekenhuis
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Aarhus, Denmark
- Aarhus Universitetshospital
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Massy, France
- Institut Hospitalier Jacques Cartier
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Toulouse, France
- Clinique Pasteur
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Bad Krozingen, Germany
- Universitaets-Herzzentrum Freiburg- Bad Krozingen
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Bonn, Germany
- Universitaetsklinikum Bonn
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Gießen, Germany
- UKGM Universitaetsklinikum Giessen
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Firenze, Italy
- AOU Careggi SOD Interventistica
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Milan, Italy
- San Raffaelle Hospital
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Rotterdam, Netherlands
- Thorax Center, Erasmus MC
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Zwolle, Netherlands
- Isala Zeikenhuis- Hartecentrum
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Madrid, Spain
- Hospital Universitario San Carlos
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Uppsala, Sweden
- Uppsala University Hospital
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London, United Kingdom
- King's College Hospital
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Oxford, United Kingdom
- Oxford University Hospitals, John Radcliffe Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient is ≥ 18 years of age
- Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure OR if troponin is elevated, concomitant CK must be normal
- The target vessel must have a TIMI flow 3 at baseline
- Patients with significant (≥ 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
- Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor) for 1 year and single antiplatelet therapy for life
- Single lesion stenosis of protected LMCA, or LAD, RCA or LCX artery ≥50% in a reference vessel of 2.5 mm - 4.0 mm diameter and ≤ 32 mm length
- Presence of calcification within the lesion on both sides of the vessel as assessed by angiography
- Planned treatment of single lesion in one vessel
- Ability to pass a 0.014" guide wire across the lesion
- Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
- Patient is able and willing to comply with all assessments in the study
Exclusion Criteria:
- Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices
- Prior PCI procedure within the last 30 days of the index procedure
- Patient has planned cardiovascular interventions within 30 days post index procedure
- Second lesion with ≥50% stenosis in the same target vessel
- Left ventricular ejection fraction < 40%
- Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
- Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
- Severe renal failure with serum creatinine >2.5 mg/dL, unless on chronic dialysis
- Untreated pre-procedural hemoglobin <10 g/dL
- Coagulopathy manifested by platelet count <100,000 or International Normalized ratio (INR) >1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment)
- Patients in cardiogenic shock
- Acute myocardial infarction (MI) within the past one (1) month, and/or signs of active myocardial ischemia at the time of enrollment including elevated Troponin-I or T (with concomitant elevation of CK), ischemic ECG changes or chest pain
- History of a stroke or transient ischemic attack (TIA) within 3 months
- NYHA class III or IV heart failure
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
- Patients with a life expectancy of less than 1 year
- Target vessel < 2.4 mm in diameter
- Target lesion > 32 mm in length
- Chronic Total Occlusion (CTO)
- Previous stent procedure within 5 mm of target lesion
- Angiographic evidence of a target lesion severe dissection prior to Coronary Lithoplasty treatment
- Unprotected Left Main diameter stenosis ≥ 50%
- Visible thrombus (by angiography) at target lesion site
- Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass
- Patient has active systemic infection
- Patient has connective tissue disease (e.g., Marfan's syndrome)
- Patient has a hypercoagulable disorder
- Uncontrolled insulin dependent diabetes
- Patient has allergy to imaging contrast media for which they cannot be pre-medicated
- Evidence of aneurysm in target vessel
- Patient is pregnant or nursing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: IVL Coronary Lithotripsy System
All enrolled patients will receive treatment from the IVL coronary lithotripsy system prior to coronary stent placement.
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The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
Time Frame: Post-procedure through hospital discharge
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The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following:
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Post-procedure through hospital discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Clinical Success
Time Frame: During procedure through hospital discharge
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Performance will be assessed by the ability of the Lithotripsy System to produce acceptable residual stenosis (<50%) after stenting with no evidence of in-hospital MACE.
Each patient that achieves both of these requirements will be considered a "clinical success", and the rate of clinical success among subjects will be evaluated.
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During procedure through hospital discharge
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Number of Participants With Angiographic Success
Time Frame: During procedure
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Angiographic success defined as success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications.
Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
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During procedure
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Number of Participants Which Experienced Cardiac Death
Time Frame: 30 days post-procedure
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Number of patients who experienced a cardiac death at 30 days post-procedure.
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30 days post-procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean Fajadet, MD, Clinic Pasteur
- Principal Investigator: Carlo DiMario, MD, University of Florence
Publications and helpful links
General Publications
- Kereiakes 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.
- Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP61774
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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