ClinicalTrials.gov
ClinicalTrials.gov Menu

Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)

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: NCT02650128
Recruitment Status : Completed
First Posted : January 8, 2016
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Shockwave Medical, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Intervention Device: Shockwave Coronary Rx Lithoplasty® System
Enrollment 60
Recruitment Details Study recruitment and enrollment took place at seven clinical sites in Australia and Europe between December 2015 and September 2016. A total of 60 subjects with calcified, stenotic de novo coronary arteries were enrolled and treated with the investigational device.
Pre-assignment Details  
Arm/Group Title Shockwave Coronary Rx Lithoplasty System
Hide Arm/Group Description

Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement

Shockwave Coronary Rx Lithoplasty® System: The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator.

Period Title: Overall Study
Started 60
30 Day Primary and Safety Endpoint 60
Completed [1] 58
Not Completed 2
Reason Not Completed
Death             2
[1]
180 day major adverse cardiac event (Post-Market Clinical Follow-up)
Arm/Group Title Shockwave Coronary Rx Lithoplasty System
Hide Arm/Group Description

Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement

Shockwave Coronary Rx Lithoplasty® System: The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator.

Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  21.7%
>=65 years
47
  78.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
12
  20.0%
Male
48
  80.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.7%
White
47
  78.3%
More than one race
0
   0.0%
Unknown or Not Reported
10
  16.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Netherlands 4
Sweden 1
United Kingdom 29
Australia 16
France 10
1.Primary Outcome
Title Safety - Frequency of Major Adverse Cardiac Events (MACE) Within 30 Days of the Procedure.
Hide Description

MACE defined as:

  • 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 the target lesion) after the completion of the index procedure
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No imputation of or adjustments for missing data were performed for the primary analyses. The population for all analysis was the Intent-To-Treat (ITT) analysis set. ITT was defined as those subjects who had insertion of the Lithoplasty catheter attempted, defined as the point of enrollment.
Arm/Group Title Shockwave Coronary Rx Lithoplasty System
Hide Arm/Group Description:

Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement

Shockwave Coronary Rx Lithoplasty® System: The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator.

Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: events
57
2.Primary Outcome
Title Performance
Hide Description

The ability of the Shockwave System to produce acceptable residual stenosis (<50%) after stenting with no evidence of in-hospital MACE.

Clinical success measured by each patient that achieves both these requirements.

Time Frame Post-procedure (within 24 hours following procedure and prior to discharge)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No imputation of or adjustments for missing data were performed for the primary analyses. The population for all analysis was the Intent-To-Treat (ITT) analysis set. ITT was defined as the subjects who had insertion of the Lithoplasty catheter attempted, defined as the point of enrollment.
Arm/Group Title Shockwave Coronary Rx Lithoplasty System
Hide Arm/Group Description:

Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement

Shockwave Coronary Rx Lithoplasty® System: The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator.

Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
57
  95.0%
3.Secondary Outcome
Title Quantitative Assessment of the Residual Stenosis in Treated Lesions
Hide Description Angiographic success defined as success in facilitating stent deliver 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 Post-procedure (within 24 hours following procedure and prior to discharge)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No imputation of or adjustments for missing data were performed for the primary analyses. The population for all analysis was the Intent-To-Treat (ITT) analysis set. ITT was defined as those subjects who had insertion of the Lithoplasty catheter attempted, defined as the point of enrollment.
Arm/Group Title Shockwave Coronary Rx Lithoplasty System
Hide Arm/Group Description:

Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement

Shockwave Coronary Rx Lithoplasty® System: The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator.

Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
58
  96.7%
4.Secondary Outcome
Title 180 Day MACE
Hide Description

MACE defined as:

  • 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 the target lesion) after the completion of the index procedure
Time Frame 180 days post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No imputation of or adjustments for missing data were performed for the primary analyses. The population for all analysis was the Intent-To-Treat (ITT) analysis set. ITT was defined as those subjects who had insertion of the Lithoplasty catheter attempted, defined as the point of enrollment.
Arm/Group Title Lithoplasty System
Hide Arm/Group Description:

Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement

Shockwave Coronary Rx Lithoplasty® System: The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator.

Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: events
58
Time Frame through 30 days and 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Shockwave Coronary Rx Lithoplasty System
Hide Arm/Group Description

Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement

Shockwave Coronary Rx Lithoplasty® System: The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator.

All-Cause Mortality
Shockwave Coronary Rx Lithoplasty System
Affected / at Risk (%)
Total   2/60 (3.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
Shockwave Coronary Rx Lithoplasty System
Affected / at Risk (%) # Events
Total   10/60 (16.67%)    
Blood and lymphatic system disorders   
Anaemia  1  1/60 (1.67%)  1
Cardiac disorders   
Angina Unstable  1  1/60 (1.67%)  1
Coronary Artery Dissection  1  3/60 (5.00%)  3
Sinus Bradycardia  1  1/60 (1.67%)  1
Gastrointestinal disorders   
Upper Gastrointestinal Haemorrhage  1  1/60 (1.67%)  1
Infections and infestations   
Cellulitis  1  1/60 (1.67%)  1
Sepsis  1  1/60 (1.67%)  1
Urinary Tract Infection  1  1/60 (1.67%)  1
Nervous system disorders   
Cerebral Hypoperfusion  1  1/60 (1.67%)  1
Renal and urinary disorders   
Renal Failure Acute  1  1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders   
Acute Pulmonary Oedema  1  1/60 (1.67%)  1
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Shockwave Coronary Rx Lithoplasty System
Affected / at Risk (%) # Events
Total   37/60 (61.67%)    
Cardiac disorders   
Bradycardia  1  1/60 (1.67%)  1
Coronary Artery Dissection  1  12/60 (20.00%)  12
Ventricular Tachycardia  1  1/60 (1.67%)  1
Gastrointestinal disorders   
Diarrhoea  1  1/60 (1.67%)  1
Gastric Ulcer  1  1/60 (1.67%)  1
Nausea  1  1/60 (1.67%)  1
Oesophageal Pain  1  1/60 (1.67%)  1
Vomiting  1  1/60 (1.67%)  1
General disorders   
Asthenia  1  1/60 (1.67%)  1
Chest Discomfort  1  2/60 (3.33%)  2
Chest Pain  1  5/60 (8.33%)  5
Puncture Site Pain  1  2/60 (3.33%)  2
Pyrexia  1  1/60 (1.67%)  1
Infections and infestations   
Lower Respiratory Tract Infection  1  1/60 (1.67%)  1
Injury, poisoning and procedural complications   
Contusion  1  1/60 (1.67%)  1
Laceration  1  1/60 (1.67%)  1
Post Procedural Haematoma  1  2/60 (3.33%)  2
Investigations   
Enzyme Level Increased  1  7/60 (11.67%)  7
Troponin Increased  1  3/60 (5.00%)  3
Metabolism and nutrition disorders   
Hyperkalaemia  1  1/60 (1.67%)  1
Musculoskeletal and connective tissue disorders   
Back Pain  1  1/60 (1.67%)  1
Groin Pain  1  2/60 (3.33%)  2
Musculoskeletal Discomfort  1  1/60 (1.67%)  1
Myalgia  1  1/60 (1.67%)  1
Nervous system disorders   
Dizziness  1  1/60 (1.67%)  1
Headache  1  3/60 (5.00%)  3
Sciatica  1  1/60 (1.67%)  1
Renal and urinary disorders   
Haematuria  1  1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/60 (1.67%)  1
Dyspnoea  1  3/60 (5.00%)  3
Productive Cough  1  1/60 (1.67%)  1
Pulmonary Mass  1  1/60 (1.67%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/60 (1.67%)  1
Vascular disorders   
Haematoma  1  2/60 (3.33%)  2
Hypertension  1  2/60 (3.33%)  2
Hypotension  1  1/60 (1.67%)  1
Thrombosis  1  1/60 (1.67%)  1
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Beaux Alexander, Vice President Clinical Affairs
Organization: Shockwave Medical, Inc.
Phone: 510-279-4262 ext 145
Responsible Party: Shockwave Medical, Inc.
ClinicalTrials.gov Identifier: NCT02650128     History of Changes
Other Study ID Numbers: TD 0257
First Submitted: December 22, 2015
First Posted: January 8, 2016
Results First Submitted: March 7, 2017
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018