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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
Sponsor:
Information provided by (Responsible Party):
Shockwave Medical, Inc.

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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).

Overall Number of Baseline Participants 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
<=18 years
0
   0.0%
Between 18 and 65 years
31
  25.8%
>=65 years
89
  74.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
Female
26
  21.7%
Male
94
  78.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
94
  78.3%
More than one race
2
   1.7%
Unknown or Not Reported
21
  17.5%
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
1.Primary Outcome
Title Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
Hide Description

The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following:

  • Cardiac death
  • Myocardial Infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave
  • TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
Time Frame Post-procedure through hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
No imputation of or adjustments for missing data were performed for the primary analysis. The population for all analysis was the Intent-To-Treat (ITT) analysis set. ITT was defined as those subjects who had insertion of the IVL catheter attempted, defined as the point of enrollment.
Arm/Group Title Coronary Intravascular Lithotripsy (IVL) System
Hide Arm/Group Description:

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).

Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
7
   5.8%
2.Secondary Outcome
Title Number of Participants With Clinical Success
Hide Description 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.
Time Frame During procedure through hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Intravascular Lithotripsy (IVL) System
Hide Arm/Group Description:

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).

Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
120
 100.0%
3.Secondary Outcome
Title Number of Participants With Angiographic Success
Hide Description 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.
Time Frame During procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Intravascular Lithotripsy (IVL) System
Hide Arm/Group Description:

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).

Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
120
 100.0%
4.Secondary Outcome
Title Number of Participants Which Experienced Cardiac Death
Hide Description Number of patients who experienced a cardiac death at 30 days post-procedure.
Time Frame 30 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Intravascular Lithotripsy (IVL) System
Hide Arm/Group Description:

All enrolled patients will receive treatment from the IVL coronary lithotripsy 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).

Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.8%
Time Frame From time of enrollment through 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Coronary Intravascular Lithotripsy (IVL) System
Hide Arm/Group Description

All enrolled patients will receive treatment from the IVL coronary lithotripsy 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).

All-Cause Mortality
Coronary Intravascular Lithotripsy (IVL) System
Affected / at Risk (%)
Total   1/120 (0.83%)    
Hide Serious Adverse Events
Coronary Intravascular Lithotripsy (IVL) System
Affected / at Risk (%) # Events
Total   13/120 (10.83%)    
Cardiac disorders   
Acute myocardial infarction  1  1/120 (0.83%)  1
Angina pectoris  1  2/120 (1.67%)  2
Arrhythmia  1  2/120 (1.67%)  2
Atrial fibrillation  1  1/120 (0.83%)  1
Coronary artery dissection  1  3/120 (2.50%)  3
Mitral valve incompetence  1  1/120 (0.83%)  1
Paroxysmal atrioventricular block  1  1/120 (0.83%)  1
Tricuspid valve incompetence  1  1/120 (0.83%)  1
Gastrointestinal disorders   
Gastrointestinal haemorrhage  1  1/120 (0.83%)  1
General disorders   
Death  1  1/120 (0.83%)  1
Infections and infestations   
Pneumonia  1  1/120 (0.83%)  1
Investigations   
Myocardial necrosis marker increased  1  1/120 (0.83%)  1
Psychiatric disorders   
Delirium  1  1/120 (0.83%)  1
Vascular disorders   
Aortic stenosis  1  1/120 (0.83%)  1
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Coronary Intravascular Lithotripsy (IVL) System
Affected / at Risk (%) # Events
Total   29/120 (24.17%)    
Cardiac disorders   
Angina pectoris  1  2/120 (1.67%)  2
Coronary artery dissection  1  4/120 (3.33%)  4
Ear and labyrinth disorders   
Vertigo  1  1/120 (0.83%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/120 (0.83%)  1
General disorders   
Malaise  1  1/120 (0.83%)  1
Infections and infestations   
Fungal skin infection  1  1/120 (0.83%)  1
Injury, poisoning and procedural complications   
Fall  1  1/120 (0.83%)  1
Vascular access site haematoma  1  3/120 (2.50%)  3
Vascular access site pain  1  2/120 (1.67%)  2
Investigations   
Myocardial necrosis marker increased  1  2/120 (1.67%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/120 (0.83%)  1
Musculoskeletal pain  1  1/120 (0.83%)  1
Pain in extremity  1  1/120 (0.83%)  1
Pain in jaw  1  1/120 (0.83%)  1
Nervous system disorders   
Sciatica  1  1/120 (0.83%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  2/120 (1.67%)  2
Skin and subcutaneous tissue disorders   
Macule  1  1/120 (0.83%)  1
Vascular disorders   
Haemodynamic instability  1  1/120 (0.83%)  1
Hypertension  1  1/120 (0.83%)  1
Orthostatic hypotension  1  1/120 (0.83%)  1
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
After publication of the multi-center Study, or earlier with Sponsor's prior written consent, the Institution may publish the results of its subjects enrolled in the Study after first complying with this Section 9 of the contract. The Institution agrees to submit any proposed publications to Sponsor for review and comment at least forty-five (45) days in advance of submitting such proposed publications to a publisher or other third party.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Beaux Alexander, Vice President of Clinical Affairs
Organization: Shockwave Medical, Inc.
Phone: 510-279-4262 ext. 145
EMail: balexander@shockwavemedical.com
Layout table for additonal information
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