Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)
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ClinicalTrials.gov Identifier: NCT03328949 |
Recruitment Status :
Completed
First Posted : November 1, 2017
Results First Posted : November 8, 2019
Last Update Posted : November 19, 2019
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Tracking Information | |||||||
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First Submitted Date ICMJE | October 27, 2017 | ||||||
First Posted Date ICMJE | November 1, 2017 | ||||||
Results First Submitted Date ICMJE | October 21, 2019 | ||||||
Results First Posted Date ICMJE | November 8, 2019 | ||||||
Last Update Posted Date | November 19, 2019 | ||||||
Actual Study Start Date ICMJE | May 18, 2018 | ||||||
Actual Primary Completion Date | March 26, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) [ Time Frame: Post-procedure through hospital discharge ] The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following:
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Original Primary Outcome Measures ICMJE |
In-hospital Major Adverse Cardiac Events (MACE) [ Time Frame: 1 day post-procedure ] The primary safety endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following:
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Shockwave Coronary Lithoplasty® Study (Disrupt CAD II) | ||||||
Official Title ICMJE | Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries | ||||||
Brief Summary | The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent. | ||||||
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Intravascular Coronary Lithotripsy System Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Coronary Artery Disease | ||||||
Intervention ICMJE | Device: IVL Coronary Lithotripsy System
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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Study Arms ICMJE | Experimental: IVL Coronary Lithotripsy System
All enrolled patients will receive treatment from the IVL coronary lithotripsy system prior to coronary stent placement.
Intervention: Device: IVL Coronary Lithotripsy System
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Publications * | 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
120 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | April 25, 2019 | ||||||
Actual Primary Completion Date | March 26, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Belgium, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03328949 | ||||||
Other Study ID Numbers ICMJE | CP61774 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Shockwave Medical, Inc. | ||||||
Study Sponsor ICMJE | Shockwave Medical, Inc. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Shockwave Medical, Inc. | ||||||
Verification Date | November 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |