Trial Outcomes & Findings for Shockwave Coronary Lithoplasty® Study (Disrupt CAD II) (NCT NCT03328949)

Last Updated: 2019-11-19

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

Post-procedure through hospital discharge

Results posted on

2019-11-19

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Coronary Intravascular Lithotripsy (IVL) System 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 Study STARTED	120
Overall Study COMPLETED	120
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Coronary Intravascular Lithotripsy (IVL) System n=120 Participants 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	89 Participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	0 Participants n=5 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	21 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 Belgium	9 participants n=5 Participants
Region of Enrollment Denmark	1 participants n=5 Participants
Region of Enrollment Italy	25 participants n=5 Participants
Region of Enrollment United Kingdom	19 participants n=5 Participants
Region of Enrollment France	19 participants n=5 Participants
Region of Enrollment Germany	29 participants n=5 Participants
Region of Enrollment Spain	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-procedure through hospital discharge

Population: 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.

Outcome measures

Outcome measures
Measure	Coronary Intravascular Lithotripsy (IVL) System n=120 Participants 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).
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)	7 Participants

SECONDARY outcome

Timeframe: During procedure through hospital discharge

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.

Outcome measures

Outcome measures
Measure	Coronary Intravascular Lithotripsy (IVL) System n=120 Participants 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).
Number of Participants With Clinical Success	120 Participants

SECONDARY outcome

Timeframe: During procedure

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.

Outcome measures

Outcome measures
Measure	Coronary Intravascular Lithotripsy (IVL) System n=120 Participants 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).
Number of Participants With Angiographic Success	120 Participants

SECONDARY outcome

Timeframe: 30 days post-procedure

Number of patients who experienced a cardiac death at 30 days post-procedure.

Outcome measures

Outcome measures
Measure	Coronary Intravascular Lithotripsy (IVL) System n=120 Participants 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).
Number of Participants Which Experienced Cardiac Death	1 Participants

Adverse Events

Coronary Intravascular Lithotripsy (IVL) System

Serious events: 13 serious events

Other events: 29 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Coronary Intravascular Lithotripsy (IVL) System n=120 participants at risk 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).
Cardiac disorders Acute myocardial infarction	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Cardiac disorders Angina pectoris	1.7% 2/120 • Number of events 2 • From time of enrollment through 30 days
Cardiac disorders Arrhythmia	1.7% 2/120 • Number of events 2 • From time of enrollment through 30 days
Cardiac disorders Atrial fibrillation	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Cardiac disorders Coronary artery dissection	2.5% 3/120 • Number of events 3 • From time of enrollment through 30 days
Cardiac disorders Mitral valve incompetence	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Cardiac disorders Paroxysmal atrioventricular block	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Cardiac disorders Tricuspid valve incompetence	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Gastrointestinal disorders Gastrointestinal haemorrhage	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
General disorders Death	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Infections and infestations Pneumonia	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Investigations Myocardial necrosis marker increased	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Psychiatric disorders Delirium	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Vascular disorders Aortic stenosis	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days

Other adverse events

Other adverse events
Measure	Coronary Intravascular Lithotripsy (IVL) System n=120 participants at risk 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).
Cardiac disorders Angina pectoris	1.7% 2/120 • Number of events 2 • From time of enrollment through 30 days
Cardiac disorders Coronary artery dissection	3.3% 4/120 • Number of events 4 • From time of enrollment through 30 days
Ear and labyrinth disorders Vertigo	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Gastrointestinal disorders Abdominal pain	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
General disorders Malaise	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Infections and infestations Fungal skin infection	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Injury, poisoning and procedural complications Fall	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Injury, poisoning and procedural complications Vascular access site haematoma	2.5% 3/120 • Number of events 3 • From time of enrollment through 30 days
Injury, poisoning and procedural complications Vascular access site pain	1.7% 2/120 • Number of events 2 • From time of enrollment through 30 days
Investigations Myocardial necrosis marker increased	1.7% 2/120 • Number of events 2 • From time of enrollment through 30 days
Musculoskeletal and connective tissue disorders Arthralgia	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Musculoskeletal and connective tissue disorders Pain in extremity	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Musculoskeletal and connective tissue disorders Pain in jaw	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Nervous system disorders Sciatica	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 2/120 • Number of events 2 • From time of enrollment through 30 days
Skin and subcutaneous tissue disorders Macule	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Vascular disorders Haemodynamic instability	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Vascular disorders Hypertension	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days
Vascular disorders Orthostatic hypotension	0.83% 1/120 • Number of events 1 • From time of enrollment through 30 days

Additional Information

Beaux Alexander, Vice President of Clinical Affairs

Shockwave Medical, Inc.

Phone: 510-279-4262 ext. 145

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER