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

Participant Flow

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
Arm/Group Description	All enrolled patients will receive ...
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

Baseline Characteristics

Arm/Group Title		Coronary Intravascular Lithotripsy (IVL) System
Arm/Group Description		All enrolled patients will receive ...
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
Baseline Analysis Population Description		[Not Specified]
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

Outcome Measures

1.Primary Outcome


Title	Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
Description	The primary endpoint is ...
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

Outcome Measure Data

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
Arm/Group Description:	All enrolled patients will receive ...
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
Description	Performance will be assessed by the ability of the Lithotripsy System ...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Coronary Intravascular Lithotripsy (IVL) System
Arm/Group Description:	All enrolled patients will receive ...
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
Description	Angiographic success defined as success in facilitating stent delivery...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Coronary Intravascular Lithotripsy (IVL) System
Arm/Group Description:	All enrolled patients will receive ...
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
Description	Number of patients who experienced a cardiac death at 30 days post-pro...
Description	Number of patients who experienced a cardiac death at 30 days post-procedure.
Time Frame	30 days post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Coronary Intravascular Lithotripsy (IVL) System
Arm/Group Description:	All enrolled patients will receive ...
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%

Adverse Events

Time Frame	From time of enrollment through 30 days
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Coronary Intravascular Lithotripsy (IVL) System
Arm/Group Description	All enrolled patients will receive ...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

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