Trial Outcomes & Findings for Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I) (NCT NCT02650128)
NCT ID: NCT02650128
Last Updated: 2018-11-02
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
30 days
Results posted on
2018-11-02
Participant Flow
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.
Participant milestones
| Measure |
Shockwave Coronary Rx Lithoplasty System
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 Study
STARTED
|
60
|
|
Overall Study
30 Day Primary and Safety Endpoint
|
60
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Shockwave Coronary Rx Lithoplasty System
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 Study
Death
|
2
|
Baseline Characteristics
Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)
Baseline characteristics by cohort
| Measure |
Shockwave Coronary Rx Lithoplasty System
n=60 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 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.
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
Outcome measures
| Measure |
Shockwave Coronary Rx Lithoplasty System
n=60 Participants
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.
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|---|---|
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Safety - Frequency of Major Adverse Cardiac Events (MACE) Within 30 Days of the Procedure.
|
57 events
|
PRIMARY outcome
Timeframe: Post-procedure (within 24 hours following procedure and prior to discharge)Population: 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.
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.
Outcome measures
| Measure |
Shockwave Coronary Rx Lithoplasty System
n=60 Participants
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.
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|---|---|
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Performance
|
57 Participants
|
SECONDARY outcome
Timeframe: Post-procedure (within 24 hours following procedure and prior to discharge)Population: 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.
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
Outcome measures
| Measure |
Shockwave Coronary Rx Lithoplasty System
n=60 Participants
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.
|
|---|---|
|
Quantitative Assessment of the Residual Stenosis in Treated Lesions
|
58 Participants
|
SECONDARY outcome
Timeframe: 180 days post-procedurePopulation: 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.
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
Outcome measures
| Measure |
Shockwave Coronary Rx Lithoplasty System
n=58 Participants
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.
|
|---|---|
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180 Day MACE
|
58 events
|
Adverse Events
Shockwave Coronary Rx Lithoplasty System
Serious events: 10 serious events
Other events: 37 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Shockwave Coronary Rx Lithoplasty System
n=60 participants at risk
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.
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|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Cardiac disorders
Angina Unstable
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Cardiac disorders
Coronary Artery Dissection
|
5.0%
3/60 • Number of events 3 • through 30 days and 6 months
|
|
Cardiac disorders
Sinus Bradycardia
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Infections and infestations
Cellulitis
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Infections and infestations
Sepsis
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Infections and infestations
Urinary Tract Infection
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Nervous system disorders
Cerebral Hypoperfusion
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
Other adverse events
| Measure |
Shockwave Coronary Rx Lithoplasty System
n=60 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Bradycardia
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Cardiac disorders
Coronary Artery Dissection
|
20.0%
12/60 • Number of events 12 • through 30 days and 6 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Gastrointestinal disorders
Gastric Ulcer
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Gastrointestinal disorders
Oesophageal Pain
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
General disorders
Asthenia
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
General disorders
Chest Discomfort
|
3.3%
2/60 • Number of events 2 • through 30 days and 6 months
|
|
General disorders
Chest Pain
|
8.3%
5/60 • Number of events 5 • through 30 days and 6 months
|
|
General disorders
Puncture Site Pain
|
3.3%
2/60 • Number of events 2 • through 30 days and 6 months
|
|
General disorders
Pyrexia
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Injury, poisoning and procedural complications
Laceration
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
3.3%
2/60 • Number of events 2 • through 30 days and 6 months
|
|
Investigations
Enzyme Level Increased
|
11.7%
7/60 • Number of events 7 • through 30 days and 6 months
|
|
Investigations
Troponin Increased
|
5.0%
3/60 • Number of events 3 • through 30 days and 6 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
3.3%
2/60 • Number of events 2 • through 30 days and 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Nervous system disorders
Dizziness
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Nervous system disorders
Headache
|
5.0%
3/60 • Number of events 3 • through 30 days and 6 months
|
|
Nervous system disorders
Sciatica
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Renal and urinary disorders
Haematuria
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
3/60 • Number of events 3 • through 30 days and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Vascular disorders
Haematoma
|
3.3%
2/60 • Number of events 2 • through 30 days and 6 months
|
|
Vascular disorders
Hypertension
|
3.3%
2/60 • Number of events 2 • through 30 days and 6 months
|
|
Vascular disorders
Hypotension
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
|
Vascular disorders
Thrombosis
|
1.7%
1/60 • Number of events 1 • through 30 days and 6 months
|
Additional Information
Beaux Alexander, Vice President Clinical Affairs
Shockwave Medical, Inc.
Phone: 510-279-4262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place