Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Conditions: Coronary Artery Disease
Sponsor: Shockwave Medical, Inc.

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Confidential – This document is property of Shockwave Medical, Inc. 
EMPOWER CAD  
NCT 05755711 
Study Title: Equity in Modifying Plaque Of WomEn with UndeRtreated Calcified Coronary Artery 
Disease (EMPOWER CAD) 
NCT Number: NCT 05755711 
Protocol Number: CP 67712 
Protocol Date: 20 July 2023 
Revision: B 
Study Device: Shockwave Medical Coronary Intravascular Lithotripsy System 
Study Sponsor Name and Address: Shockwave Medical, Inc. 
5403 Betsy Ross Drive 
Santa Clara, CA 95054 
USA 
CONFIDENTIAL 
THIS STUDY PROTOCOL CONTAINS CONFIDENTIAL INFORMATION FOR USE BY THE INVESTIGATORS AND THEIR 
DESIGNATED REPRESENTATIVES. IT SHOULD BE HELD CONFIDENTIAL AND MAINTAINED IN A SECURE 
LOCATION.  IT SHOULD NOT BE COPIED OR MADE AVAILABLE FOR REVIEW BY ANY UNAUTHORIZED PERSON OR 
FIRM WITHOUT WRITTEN PERMISSION FROM SHOCKWAVE MEDICAL, INC. 

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1. Study Summary 
Study Title  
Equity in Modifying Plaque Of WomEn with UndeRtreated Calcified 
Coronary Artery Disease (EMPOWER CAD) 
Study Objective  
To generate real-world clinical evidence associated with coronary 
IVL in a population of female subjects with calcified coronary artery 
disease.  
Study Device(s), 
commercially 
available  
Shockwave Medical Coronary IVL System 
Manufacturer 
Shockwave Medical, Inc. 
Intended Use 
The Shockwave Coronary IVL System is intended to treat calcified 
stenoses, including calcified stenoses that are anticipated to 
exhibit resistance to full balloon dilatation or subsequent uniform 
coronary stent expansion. 
Study Design 
Post-market, prospective, multi-center, single-arm observational 
study 
Enrollment 
Up to 400 subjects at up to 50 global sites in the US, UK and 
Europe   
Subject Population 
Female subjects referred for percutaneous coronary intervention 
(PCI) with coronary IVL and stenting per standard of care. 
Study Duration / 
Follow-Up Period 
Subjects will have clinical follow-up prior to discharge from the 
index procedure and at 30 days, 1, 2 and 3 years.  Follow-up will 
be via telephone contact (or optional clinic visit). 
Primary Safety 
Endpoint 
Target lesion failure (TLF) at 30 days defined as a composite of 
cardiac death, myocardial infarction (per SCAI definition for peri-
procedural MI; per 4th Universal Definition for spontaneous MI 
beyond discharge) attributable to target vessel (TV-MI), or 
ischemia-driven target lesion revascularization (ID-TLR).   
Primary Effectiveness 
Endpoint 
Procedural Success defined as stent delivery with a residual in-
stent stenosis ≤30% in all target lesions (core laboratory assessed) 
and without in-hospital TLF (CEC adjudicated).  

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Secondary Endpoints: 
• 
Angiographic Success defined as stent delivery with ≤30% 
residual stenosis and without serious angiographic 
complications. 
• 
Procedural Success defined as stent delivery with a residual 
stenosis <50% in all target lesions (core laboratory assessed) 
and without in-hospital TLF. 
• 
Angiographic Success defined as 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. 
• 
TLF at 1, 2 and 3 years. 
• 
Major Adverse Cardiac Events (MACE) defined as a composite 
of cardiac death, myocardial infarction (per SCAI definition for 
peri-procedural MI; per 4th Universal Definition for 
spontaneous MI beyond discharge), and target vessel 
revascularization at 30 days, 1, 2 and 3 years. 
• 
At each time period: All death, cardiac death, MI, TV-MI, 
procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-
TLR, ID-non-TVR, all revascularizations (ID and non-ID), and 
stent thrombosis (ARC definite, probable, definite or probable). 
• 
MI rates and all composite endpoints (TLF, MACE) will also be 
reported using the 4th Universal Definition for peri-procedural 
and spontaneous MI at all timepoints.  
• 
Angina symptoms assessed as a change from baseline (at 
each time period) by Seattle Angina Questionnaire (SAQ-7).  
• 
Quality of life assessed by EQ-5D-5L as a change from 
baseline (at each time period).  
• 
Quality of life assessed by Generalized Anxiety Disorder 
Questionnaire (GAD-7) as a change from baseline (at each 
time period). 
Optical Coherence 
Tomography (OCT) 
Sub-study 
Up to 200 consecutive subjects who consent to participate in the 
OCT sub study will undergo OCT assessment at baseline, 
immediately post-IVL /or post-adjunctive device, and end of 
procedure (after stent implantation / post-dilatation). The OCT sub 
study will be performed at pre-selected qualified sites. 
Study Inclusion 
Criteria 
1. The subject is a non-pregnant female ≥18 years of age 
2. The subject meets indications for PCI and stent 
3. The subject is scheduled to undergo PCI with coronary IVL and 
stenting per standard of care for non-stented lesion 
4. The subject is willing to comply with protocol-specified follow-up 
evaluations 
5. The subject, or legally authorized representative, has been 

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EMPOWER CAD  
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informed of the nature of the study, agrees to its provisions, and 
has provided written informed consent, approved by the 
appropriate Institutional Review Board (IRB) or Ethics 
Committee (EC) 
Study Exclusion 
Criteria 
1. Subjects with known mental or physical illness or known history 
of substance abuse that may cause non-compliance with the 
protocol, confound the data interpretation, or is associated with 
a life expectancy of less than one year 
2. Subjects presenting with cardiogenic shock at the time of the 
index procedure 
3. Serious angiographic complication in the target vessel prior to 
treatment with coronary IVL including severe dissection (Type D 
to F), perforation, abrupt closure, persistent slow-flow or 
persistent no reflow  
4. Subject unable to tolerate anticoagulation/antiplatelet therapy 
per guidelines 
5. Subject is enrolled in any study of an investigational device or 
drug that may interfere with study results 
Study Statistical 
Methods 
• 
Intent-to-Treat (ITT) analysis with pre-defined subgroups 
• 
Designed to assess exact 95% confidence interval (CI) for 
primary endpoints; no formal hypothesis testing  
Study Sponsor/Study 
Management 
Shockwave Medical, Inc. 
5403 Betsy Ross Drive 
Santa Clara, CA 95054 
USA 
 
Contact: Randee Randoll 
Title: Director, Clinical Affairs 
Telephone (direct): 408.550.2626 
Email: rrandoll@shockwavemedical.com 
 
 
  
  
  
  
 
 
 
  
  
  
  
  
 
 
 
 
 
 
 
 
  

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1.0 
INTRODUCTION/BACKGROUND 
1.1 Calcified Coronary Lesions 
Coronary artery calcification (CAC) is common especially in the elderly population and those 
with more advanced disease. Approximately 38% and 73% of all lesions display calcification as 
detected by angiography and intravascular ultrasound (IVUS), respectively [1]. As IVUS is not 
routinely used as a diagnostic modality, coronary calcification is most likely underestimated [2].  
 
Conventional percutaneous coronary intervention (PCI) to treat calcified lesions has a greater 
risk of stent underexpansion and malapposition, both of which are associated with adverse 
clinical outcomes [3]. To facilitate stent placement and optimize stent expansion in calcified 
lesions, adjunctive plaque-modifying devices are often used including atherectomy (rotational, 
orbital, laser) and cutting/scoring balloons [4]. Despite advances in interventional equipment and 
techniques, effective treatment for patients with advanced coronary calcification remains a 
challenge. Compared to non-calcified lesions, calcified coronary lesions are associated with a 
higher incidence of major adverse cardiac events (MACE), especially, the rate of non–Q-wave 
myocardial infarction (MI) [5]. Calcified lesions are associated with a high frequency of 
restenosis, target lesion revascularization (TLR), vessel dissection during PCI, failure to deliver 
a stent, balloon ruptures and undilatable lesions [2]. In a study of pooled data from 6,855 
patients, the presence of calcification was associated with an increase in the rate of ischemic 
events at 1 year, especially within the first 30 days, reflecting the negative impact of calcification 
during stent implantation resulting in an increase in acute and subacute stent failure [6]. 
 
Women with moderate-to-severe lesion calcium are particularly vulnerable to poor outcomes. In 
a dedicated DES registry of 6371 female patients, of which 1622 (25.5%) had moderate/severe 
calcium, outcomes at 3 years were significantly worse with a reported 38% higher mortality, a 
48% higher rate of death or myocardial infarction (MI), and a 56% higher rate of death, MI, or 
target lesion revascularization (TLR) compared with treatment of mildly or noncalcified lesions 
[7]. Plaque modification with atherectomy improves lesion compliance, allowing optimal stent 
expansion, but is associated with increased periprocedural complications including coronary 
dissections, perforation, and higher rates of periprocedural MI [2, 8, 9]. The procedural risks of 
atherectomy are accentuated in women who have rates of serious flow-limiting coronary 
dissections and cardiac tamponade that are 4- to 5-fold higher than men treated with rotational 
atherectomy, leading to 2-fold higher rates of in-hospital major adverse cardiac events (MACE) 
[10]. Similar results have been reported with orbital atherectomy [11]. Acute procedural 
complications in women may limit the use of atherectomy to optimize DES expansion (one of 
the strongest predictors of subsequent stent thrombosis and restenosis) [12, 13] and likely 
contribute to the poor outcomes reported in the longer term. 
1.2 Coronary Intravascular Lithotripsy 
Lithotripsy is a technology originally designed to fragment renal calcifications by pulsing them 
with high-power acoustic shock waves [14].  The design concept of the Shockwave Coronary 
IVL System is to use the same core lithotripsy technology, albeit at energy levels that are 
orders of magnitude lower in intensity and number [15]. The Shockwave Coronary IVL catheter 
is based on conventional balloon catheter concepts; however, the balloon is inflated at a lower 
than nominal pressure and the lithotripsy emitters are energized thereby generating pulsatile 
mechanical energy within the balloon at the target treatment site, disrupting calcium within the 

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lesion, and allowing subsequent dilatation of coronary artery stenosis using low balloon 
pressure.   
The Shockwave Coronary IVL System has been evaluated as an adjunct to coronary stenting in 
severely calcified lesions in the four Disrupt CAD studies: Disrupt CAD I-IV [16-19]. These 
individual single-arm, prospective, multicenter, nonrandomized studies demonstrated high rates 
of device and procedural success as well as excellent early angiographic and clinical 
outcomes, providing evidence for device performance and safety as well as insights into the 
mechanism(s) of calcium modification. 
A patient-level pooled analysis was completed for the Disrupt CAD I-IV studies which showed 
the very low rates of serious angiographic complications in the pooled analysis are consistent 
with the IVL mechanism of action which involves circumferential and longitudinal multiplane 
calcium fracture in situ without the generation of atheroembolic debris and/or significant heat 
energy [20]. In severely calcified lesions, IVL improves vessel compliance, mitigating the need 
for aggressive high-pressure balloon dilatation prior to stent delivery, with its associated 
potential for barotrauma and severe dissection. This unique mechanism of action is reflected by 
the significant improvements observed by quantitative coronary angiography in minimal luminal 
diameter (MLD) and percentage diameter stenosis after IVL alone despite an average peak IVL 
balloon pressure of only 6 atm [15]. 
An additional analysis was performed on the patient-level pooled data from the Disrupt CAD I-
IV studies to evaluate sex-based outcomes of severely calcified coronary lesions treated with 
IVL lesion preparation before stent implantation [21]. Results showed that IVL-facilitated DES 
implantation was safe and effective independent of patient sex and was associated with 
infrequent angiographic complications, without evidence of excess acute angiographic or 
clinical complications in women [21]. 
1.3 Study Rationale 
The pooled Disrupt CAD I-IV analysis represents the largest series evaluating sex-based 
outcomes with coronary IVL and included data from 144 women. The EMPOWER CAD study is 
designed to expand upon this clinical foundation by prospectively enrolling up to 400 female 
patients and addressing some of the limitations of the pooled analysis [21].  Specifically, 
EMPOWER CAD is an all-comers study which will enroll a broader population including patients 
with acute coronary syndromes and those with more complex lesions that were excluded from 
the CAD I-IV studies including ostial, unprotected left main, length >40 mm, and those lesions 
with moderate calcium.  The EMPOWER CAD study will also provide longer-term outcomes up 
to three years.  Lastly, by generating real-world clinical evidence associated with coronary IVL in 
a population of female patients with calcified coronary artery disease, the EMPOWER CAD 
study aims to directly address the underrepresentation of women in cardiovascular clinical trials 
[22].   

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2.0 
Study Device Description 
2.1 Shockwave Coronary IVL System 
 
The commercially available Shockwave Coronary IVL System consists of an IVL Catheter that is 
used exclusively with the IVL Generator, IVL Connector Cable and its accessories. The IVL 
Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter 
and is used to activate the lithotripsy therapy from the IVL Generator, refer to Figure 1. 
Representative Shockwave IVL System. 
 
Figure 1. Representative Shockwave IVL System 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2.4 Indications for Use  
The Shockwave Coronary IVL System (study devices) utilized during the conduct of this study will 
be commercially available. Refer to the associated IFUs for each country’s approved device 
indication.   
 
 

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3.0 
STATISTICAL CONSIDERATIONS 
3.1 General Statistical Methods 
Descriptive statistics will be provided in this clinical study.  Analyses will be conducted at pre-
specified time points including 30 days, 1, 2 and 3 years. 
Categorical variables will be summarized by the number of observations available, frequency, 
and percentage. Unless otherwise noted, missing data will be excluded from the denominator. 
Comparisons will utilize a Chi-square test, or Fisher’s exact test when 20% or more of expected 
cell frequencies are less than 5. Clinical outcomes analyzed at 30 days will be evaluated as 
categorical (binary) data.  McNemar’s chi-square may be used to assess within-subject changes 
in a bivariate response variable. Exact confidence intervals will be generated for estimates of 
proportions.   
Continuous variables will be summarized by the mean, standard deviation, median, minimum, 
and maximum.  Within-subject changes will be analyzed parametrically using the Paired t-test if 
the differences are normally distributed, or non-parametrically using the Sign-Rank Test if the 
differences are not normally distributed. Asymptotic confidence intervals will be generated for 
estimates of means.   
   
 
3.2 Primary Endpoints 
 
 
3.2.1 Primary Safety Endpoint  
The primary safety endpoint is freedom from Target Lesion Failure (TLF) at 30 days, defined 
as a composite of: 
• 
Cardiac death, or 
• 
Myocardial Infarction (per SCAI definition for peri-procedural MI; per 4th Universal 
Definition for spontaneous MI beyond discharge) attributable to target vessel (TV-MI), 
or 
• 
Ischemia-driven target lesion revascularization (ID-TLR)  
 
3.2.2 Primary Effectiveness Endpoint  
The primary effectiveness endpoint is Procedural Success defined as stent delivery with a 
residual in-stent stenosis ≤30% in all target lesions (core laboratory assessed) and without in-
hospital TLF (CEC adjudicated). 
 
 
3.3 Sample Size Determination 
The sample size was calculated based on the precision of the exact 2-sided 95% confidence interval 
(CI) of the primary effectiveness endpoint, using Disrupt CAD III female subgroup results as a 
reference [18].
 

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The calculation of the EMPOWER CAD sample size was based on a procedural success estimate of 
90.0%. Combined with a desired precision of +/- 3.1% and an alpha of 0.05 (95% CI), a sample size 
of 360 was selected to provide a probability width (“power”) of 0.8. Assuming a lost-to-follow-up rate 
of 10%, up to 400 subjects will be enrolled. 
 
The EMPOWER CAD study will enroll a broader population relative to the prior pooled analysis from 
CAD I-IV; as such, point estimates from this real-world population may be used as reference for 
future studies. 
 
 
3.4 Population Analysis 
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled 
subjects. 
 
3.5 Handling of Dropout of Missing Data 
No imputation of or adjustments for missing data will be performed for the primary analyses. All 
available data will be presented.  For time to event analyses, subjects who do not experience the 
event in question will be censored at their last known follow-up. 
 
 
 

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5.0 
Index Procedure 
5.1 Coronary Intravascular Lithotripsy Procedure 
A full description of the IVL procedure is detailed in the Instructions for Use (IFU) including 
appropriate balloon sizing.  Note that there are specific IFUs and labelling provided for the 
United States (US) and for Outside of the US (OUS). An appropriately-sized IVL catheter 
should be selected per the IFU. 
The recommended procedural steps outlined below represent an “IVL first” approach; 
adjunctive devices may be used if there are challenges after first attempting to cross with the 
IVL catheter
 
 Any departures from this algorithm will not be considered protocol 
deviations; information on all devices used in the procedure (including the order in which 
they were used) will be captured. Angiographic images captured during the procedure will be 
sent to the core lab for analysis. 
• 
If multiple lesions are to be treated, it is recommended that non-target lesions be 
preferentially treated first. 
• 
If a serious angiographic complication occurs in a target or non-target vessel prior to 
insertion of the IVL catheter, the subject should be treated per standard of care; 
however, they should not be enrolled in the study. 
• 
If the Investigator is able to pass a guidewire but is unable to pass the IVL catheter 
across the target lesion, an adjunctive tool (balloon, atherectomy, cutting/scoring balloon) 
may be used prior to re-insertion of the IVL Catheter. The lesion will then be treated per 
the IFU with the IVL Catheter.  
             Note: Pre-dilatation may be performed using standard techniques based on physician 
discretion. 
• 
The subject is considered enrolled once the IVL Catheter has been inserted into 
             the access artery. 
• 
Once the IVL catheter is placed in the target lesion area, the balloon should be inflated to 
4 atm and IVL treatment delivered for the pre-programmed time of 10 seconds to deliver 
10 pulses.   
Note: The IVL Generator is programmed to force a minimum pause time of 10 
seconds following every 10 pulses delivered.  
• 
Following IVL, inflate the balloon to the reference size using the balloon compliance chart 
(refer to IFU) and record lesion response on fluoroscopy. 
• 
Deflate the balloon to re-establish blood flow. 
• 
Repeat prior steps for additional treatment cycles until the lesion has been sufficiently 
dilated or the catheter is re-positioned. 
If additional lesion area needs to be treated, follow the treatment steps identified above and 
per the IFU to ensure appropriate overlap between segments
   
Note: The maximum number of pulses to treat a single arterial segment is 80 pulses 
and therefore 160 pulses in an overlap segment.  Additional catheters may be used 
when necessary.  

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EMPOWER CAD  
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• 
The residual stenosis will be assessed by the physician following the IVL procedure.  The 
IVL procedure is considered successful when the residual stenosis allows for adequate 
balloon expansion by visual estimate, as determined by the Investigator prior to stent 
placement.  Consider additional IVL pulses if needed to optimize residual stenosis.  
• 
If the residual stenosis is sub-optimal following IVL, a balloon or other adjunctive device 
(atherectomy, cutting/scoring balloon) must be used to dilate the lesion prior to stenting.  
This information will be recorded in the case report form.   
• 
Post-IVL angiography should be performed after IVL pulses have been delivered  and 
prior to stent delivery. 
• 
The stent will then be delivered using a standard approach.  
• 
Following stent implantation, post-dilatation with a non-compliant balloon with inflation 
pressure ≥16 atm is strongly recommended. 
• 
Following delivery of the coronary stent and post-dilatation, angiography will be 
performed to determine the final residual stenosis for assessment of the primary 
effectiveness endpoint.   

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5.2 Optical Coherence Tomography (OCT) Sub-study 
For subjects enrolled in the OCT Sub-study, OCT images must be assessed at baseline, 
immediately post-IVL (or post-adjunctive therapy), and end of procedure. 
 
 
6.0 References  
1.    Mintz, G.S., Intravascular imaging of coronary calcification and its clinical implications. JACC Cardiovasc 
Imaging, 2015. 8(4): p. 461-471. 
2. Chambers, J.W., et al., Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system 
in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv, 2014. 7(5): p. 
510-8. 
3. Genereux, P., et al., Two-year outcomes after percutaneous coronary intervention of calcified lesions with 
drug-eluting stents. Int J Cardiol, 2017. 231: p. 61-67. 
4. Shavadia, J.S., M.N. Vo, and K.R. Bainey, Challenges With Severe Coronary Artery Calcification in 
Percutaneous Coronary Intervention: A Narrative Review of Therapeutic Options. Can J Cardiol, 2018. 
34(12): p. 1564-1572. 
5. Mosseri, M., et al., Impact of vessel calcification on outcomes after coronary stenting. Cardiovasc Revasc 
Med, 2005. 6(4): p. 147-53. 
6. Genereux, P., et al., Ischemic outcomes after coronary intervention of calcified vessels in acute coronary 
syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and 

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Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage 
Strategy) TRIALS. J Am Coll Cardiol, 2014. 63(18): p. 1845-54. 
7. Giustino, G., et al., Correlates and Impact of Coronary Artery Calcifications in Women Undergoing 
Percutaneous Coronary Intervention With Drug-Eluting Stents: From the Women in Innovation and Drug-
Eluting Stents (WIN-DES) Collaboration. JACC Cardiovasc Interv, 2016. 9(18): p. 1890-901. 
8. Kini, A.S., et al., Optical coherence tomography assessment of the mechanistic effects of rotational and 
orbital atherectomy in severely calcified coronary lesions. Catheter Cardiovasc Interv, 2015. 86(6): p. 
1024-32. 
9. Abdel-Wahab, M., et al., High-speed rotational atherectomy before paclitaxel-eluting stent implantation 
in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus 
Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv, 2013. 6(1): p. 
10-9. 
10. Ford, T.J., et al., Sex differences in procedural and clinical outcomes following rotational atherectomy. 
Catheter Cardiovasc Interv, 2020. 95(2): p. 232-241. 
11. Kim, C.Y., et al., Gender differences in acute and 30-day outcomes after orbital atherectomy treatment of 
de novo, severely calcified coronary lesions. Catheter Cardiovasc Interv, 2016. 87(4): p. 671-7. 
12. Kobayashi, Y., et al., Impact of Target Lesion Coronary Calcification on Stent Expansion. Circulation 
Journal, 2014. 78(9): p. 2209-2214. 
13. Choi, K.H., et al., Impact of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention on 
Long-Term Clinical Outcomes in Patients Undergoing Complex Procedures. JACC Cardiovasc Interv, 2019. 
12(7): p. 607-620. 
14. Powers, C.J., M.M. Tinterow, and J.F. Burpee, Extracorporeal shock wave lithotripsy: a study of renal 
stone differences. Kans Med, 1989. 90(1): p. 19-22. 
15. Kereiakes, D.J., et al., Principles of Intravascular Lithotripsy for Calcific Plaque Modification. JACC: 
Cardiovascular Interventions, 2021. 14(12): p. 1275-1292. 
16. Ali, Z.A., et al., Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely 
Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv, 2019. 12(10): p. e008434. 
17. Brinton, T.J., et al., Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of 
Calcified Coronary Stenoses: First Description. Circulation, 2019. 139(6): p. 834-836. 
18. Hill, J.M., et al., Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease: The 
Disrupt CAD III Study. J Am Coll Cardiol, 2020. 76(22): p. 2635-46. 
19. Saito, S., et al., Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries 
Prior to Stent Placement- Primary Outcomes From the Japanese Disrupt CAD IV Study. Circ J, 2021. 85(6): 
p. 826-833. 
20. Kereiakes, D.J., et al., Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level 
Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv, 2021. 14(12): p. 1337-1348. 
21. Hussain, M.A., Sex-Specific Outcomes After Coronary Intravascular Lithotripsy: A Patient-Level Analysis of 
the Disrupt CAD Studies. JSCAI, 2022. 
22. Cho, L., et al., Increasing Participation of Women in Cardiovascular Trials: JACC Council Perspectives. J Am 
Coll Cardiol, 2021. 78(7): p. 737-751.