Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)
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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. Read our disclaimer for details. |
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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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Coronary Artery Disease |
Intervention |
Device: IVL Coronary Lithotripsy System |
Enrollment | 120 |
Recruitment Details | Study recruitment and enrollment took place at 15 clinical sites in 9 European countries between May 2018 and March 2019. A total of 120 subjects with calcified, stenotic de novo coronary arteries were enrolled and treated with the Coronary Intravascular Lithotripsy (IVL) System. |
Pre-assignment Details |
Arm/Group Title | Coronary Intravascular Lithotripsy (IVL) System |
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All enrolled patients will receive treatment from the coronary intravascular lithotripsy (IVL) system prior to coronary stent placement. Coronary Intravascular Lithotripsy (IVL) 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). |
Period Title: Overall Study | |
Started | 120 |
Completed | 120 |
Not Completed | 0 |
Arm/Group Title | Coronary Intravascular Lithotripsy (IVL) System | |
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All enrolled patients will receive treatment from the coronary intravascular lithotripsy (IVL) system prior to coronary stent placement. Coronary Intravascular Lithotripsy (IVL) 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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Overall Number of Baseline Participants | 120 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 120 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
31 25.8%
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>=65 years |
89 74.2%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 120 participants | |
Female |
26 21.7%
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Male |
94 78.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 120 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
3 2.5%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
94 78.3%
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More than one race |
2 1.7%
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Unknown or Not Reported |
21 17.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 120 participants |
Netherlands | 4 | |
Sweden | 1 | |
Belgium | 9 | |
Denmark | 1 | |
Italy | 25 | |
United Kingdom | 19 | |
France | 19 | |
Germany | 29 | |
Spain | 13 |
Name/Title: | Beaux Alexander, Vice President of Clinical Affairs |
Organization: | Shockwave Medical, Inc. |
Phone: | 510-279-4262 ext. 145 |
EMail: | balexander@shockwavemedical.com |
Responsible Party: | Shockwave Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT03328949 |
Other Study ID Numbers: |
CP61774 |
First Submitted: | October 27, 2017 |
First Posted: | November 1, 2017 |
Results First Submitted: | October 21, 2019 |
Results First Posted: | November 8, 2019 |
Last Update Posted: | November 19, 2019 |