Disrupt CAD III With the Shockwave Coronary IVL System | NCT03595176

Label	Type	Description	Intervention Names
Coronary Lithotripsy System	Experimental	All subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System	Device: Lithotripsy

Name	Type	Description	Arm Group Labels	Other Names
Lithotripsy	Device	Deliver Lithotripsy to the target vessel prior to placing a coronary stent.	Coronary Lithotripsy System

Measure	Description	Time Frame
Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure	The primary safety endpoint was freedom from MACE at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Pivotal Analysis Set.	within 30 days of index procedure
Number of Participants With Procedural Success (Residual Stenosis <50%)	The primary effectiveness endpoint was Procedural Success defined as stent delivery with a residual in-stent stenosis <50% (core laboratory assessed) and without in-hospital MACE. The primary endpoints were analyzed using the Pivotal Analysis Set.	12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure

Measure	Description	Time Frame
Number of Participants With Device Crossing Success	Device Crossing Success defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL. The secondary endpoints were analyzed using the Pivotal Analysis Set.	at end of procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is ≥18 years of age
Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure (note: if both labs are drawn, both must be normal).
For patients with stable ischemic heart disease, biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath.
1. If drawn prior to the procedure, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours of the procedure (note: if both labs are drawn, both must be normal).
2. If biomarkers are drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analyzed prior to enrollment (note: CK-MB is required if drawn from the sheath).
Left ventricular ejection fraction >25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criteria; may be assessed at time of index procedure)
Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
Lesions in non-target vessels requiring PCI may be treated either:
1. >30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
2. >24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis <30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and with no post-procedure biomarker elevation >normal; or
3. >30 days after the study procedure
Angiographic Inclusion Criteria
The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with:
1. Stenosis of ≥70% and <100% or
2. Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
The lesion length must not exceed 40 mm
The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre- dilatation)
Evidence of calcification at the lesion site by, a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section
Ability to pass a 0.014" guide wire across the lesion

Exclusion Criteria:

Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
Subject is a member of a vulnerable population as defined in 21 CFR 56.111, including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention
Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months (for patients not on oral anticoagulation)
Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK-MB greater than 1 times the local laboratory's upper limit of normal
New York Heart Association (NYHA) class III or IV heart failure
Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit
Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
Coagulopathy, including but not limited to platelet count <100,000 or International Normalized ratio (INR) > 1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders
Uncontrolled diabetes defined as a HbA1c greater than or equal to 10%
Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia)
Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
Subjects with a life expectancy of less than 1 year
Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure
Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure
Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
High SYNTAX Score (≥33) if assessed as standard of care, unless the local heart team has met and recommends PCI is the most appropriate treatment for the patient
Unprotected left main diameter stenosis >30%
Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º
Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
Evidence of aneurysm in target vessel within 10 mm of the target lesion
Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion
Target lesion is a bifurcation with ostial diameter stenosis ≥30%
Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches
Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
Previous stent within the target vessel implanted within the last year
Previous stent within 10 mm of the target lesion regardless of the timing of its implantation
Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage

Name	Affiliation	Role
Dean J Kereiakes, MD,FACC,FSCAI	The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital	Study Chair
Gregg W Stone, MD,FACC,FSCAI	Columbia University	Study Chair
Jonathan Hill, MD	Royal Brompton and Harefield NHS Foundation Trust	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Honor Health		Scottsdale	Arizona	85258	United States
Scripps Clinic

PubMed Identifier	Type	Citation	Retractions
33069849	Result	Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15.
32470635

Label	URL
Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Lesions: 1-Year Results From the Disrupt CAD III Study	View source

ID	Title	Description
FG000	Coronary IVL System (Roll-In)	The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30 days, at which time subject participation was complete.
FG001	Coronary IVL System (Pivotal)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 5, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure

The primary safety endpoint was freedom from MACE at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Primary Outcome Measure; therefore, only pivotal group is reported. Additionally, one subject was excluded from the primary safety endpoint analysis due to insufficient follow-up (<23 days).

Posted

Number

95% Confidence Interval

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000383

Title

Denominators

Categories

Title	Measurements
	OG00092.2(89.9 to NA)The hypothesis test was a one-sided asymptotic Wald (normal approximation-based) confidence interval for a binomial proportion against a performance goal.

Primary

Number of Participants With Procedural Success (Residual Stenosis <50%)

The primary effectiveness endpoint was Procedural Success defined as stent delivery with a residual in-stent stenosis <50% (core laboratory assessed) and without in-hospital MACE. The primary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Primary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

95% Confidence Interval

percentage of participants

12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Device Crossing Success

Device Crossing Success defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Count of Participants

Participants

at end of procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Angiographic Success (Residual Stenosis <50%)

Angiographic Success defined as stent delivery with <50% residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Count of Participants

Participants

at end of procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Procedural Success (Residual Stenosis <=30%)

Procedural Success defined as stent delivery with a residual stenosis <=30% (core laboratory assessed) and without in-hospital MACE. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Count of Participants

Participants

12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Angiographic Success (Residual Stenosis <=30%)

Angiographic Success defined as stent delivery with <=30% residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Count of Participants

Participants

at end of procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Number of Participants With 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. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Count of Participants

Participants

at end of procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

MACE Rate at 6 Months

MACE at 6 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

MACE Rate at 12 Months

MACE at 12 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

MACE Rate at 24 Months

MACE at 24 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Target Lesion Failure (TLF) Rate at 30 Days

Target lesion failure (TLF) is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. 30 day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Target Lesion Failure (TLF) Rate at 6 Months

TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Target Lesion Failure (TLF) Rate at 12 Months

TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Target Lesion Failure (TLF) Rate at 24 Months

TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

All-Cause Death Rate at 30 Days

30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

All-Cause Death Rate at 6 Months

All-cause death at 6 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

All-Cause Death Rate at 12 Months

All-cause death at 12 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

All-Cause Death Rate at 24 Months

All-cause death at 24 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Cardiac Death Rate at 30 Days

30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Cardiac Death Rate at 6 Months

Cardiac death at 6 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Cardiac Death Rate at 12 Months

Cardiac death at 12 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Cardiac Death Rate at 24 Months

Cardiac death at 24 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

MI Rate at 30 Days

30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

MI Rate at 6 Months

MI is presented as a Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

MI Rate at 12 Months

MI is presented as a Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

MI Rate at 24 Months

MI is presented as a Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Target Vessel-Myocardial Infarction (TV-MI) Rate at 30 Days

30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

TV-MI Rate at 6 Months

TV-MI is presented as a Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

TV-MI Rate at 12 Months

TV-MI is presented as a Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

TV-MI Rate at 24 Months

TV-MI is presented as a Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Procedural MI Rate at 30 Days

Periprocedural MI defined as CK-MB > 3x upper limit of lab normal (ULN). 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Procedural MI Rate at 6 Months

Periprocedural MI defined as CK-MB > 3x upper limit of lab normal (ULN). For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Procedural MI Rate at 12 Months

Periprocedural MI defined as CK-MB > 3x upper limit of lab normal (ULN). For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Procedural MI Rate at 24 Months

Periprocedural MI defined as CK-MB > 3x upper limit of lab normal (ULN). For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Non-Procedural MI Rate at 30 Days

Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Non-Procedural MI Rate at 6 Months

Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Non-Procedural MI Rate at 12 Months

Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Non-Procedural MI Rate at 24 Months

Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Ischemia-Driven Target Vessel Revascularization (ID-TVR) Rate at 30 Days

30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

ID-TVR Rate at 6 Months

For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

ID-TVR Rate at 12 Months

For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

ID-TVR Rate at 24 Months

For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days

30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

ID-TLR Rate at 6 Months

For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

ID-TLR Rate at 12 Months

For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

ID-TLR Rate at 24 Months

For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Non-ID-TVR Rate at 30 Days

30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Non-ID-TVR Rate at 6 Months

For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Non-ID-TVR Rate at 12 Months

For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Non-ID-TVR Rate at 24 Months

For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Non-ID-TLR Rate at 30 Days

30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Non-ID-TLR Rate at 6 Months

For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Non-ID-TLR Rate at 12 Months

For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Non-ID-TLR Rate at 24 Months

For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Any Revascularizations Rate at 30 Days

Any revascularizations (ID and non-ID) at 30 days. 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Any Revascularizations Rate at 6 Months

Any revascularizations (ID and non-ID) at 6 months, presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Any Revascularizations Rate at 12 Months

Any revascularizations (ID and non-ID) at 12 months, presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Any Revascularizations Rate at 24 Months

Any revascularizations (ID and non-ID) at 24 months, presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis Rate at 30 Days

Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis Rate at 6 Months

Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis Rate at 12 Months

Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis Rate at 24 Months

Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Rate of MI Using the 4th Universal Definition at 30 Days

30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Rate of MI Using the 4th Universal Definition at 6 Months

For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Rate of MI Using the 4th Universal Definition at 12 Months

For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Rate of MI Using the 4th Universal Definition at 24 Months

For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Rate of MI Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition at 30 Days

30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 30 days of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Rate of MI Using the SCAI Definition at 6 Months

For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 6 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Rate of MI Using the SCAI Definition at 12 Months

For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 12 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Secondary

Rate of MI Using the SCAI Definition at 24 Months

For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.

Posted

Number

percentage of participants

within 24 months of index procedure

ID	Title	Description
OG000	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0025 events5 affected384 at risk EG0035 events5 affected384 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0022 events2 affected384 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Coronary artery dissection	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0001 events1 affected47 at risk EG00111 events11 affected384 at risk EG00211 events11 affected384 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG00110 events8 affected384 at risk EG00218 events16 affected384 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG00110 events6 affected384 at risk EG00220 events15 affected384 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0015 events5 affected384 at risk EG00221 events15 affected384 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0012 events2 affected384 at risk EG0023 events3 affected384 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0001 events1 affected47 at risk EG0011 events1 affected384 at risk EG0024 events4 affected384 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0022 events2 affected384 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0025 events4 affected384 at risk EG003
Coronary artery perforation	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Coronary artery thrombosis	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0022 events2 affected384 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Congenital coronary artery malformation	Congenital, familial and genetic disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0015 events5 affected384 at risk EG0029 events8 affected384 at risk EG003
Pain	General disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Pyrexia	General disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment		EG0001 events1 affected47 at risk EG0012 events2 affected384 at risk EG0026 events6 affected384 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Skin wound	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Vascular access site haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Myocardial necrosis marker increased (elevated cardiac biomarker)	Investigations	MedDRA 21.1	Systematic Assessment	Cardiac biomarker includes troponin or CK-MB	EG0001 events1 affected47 at risk EG0012 events2 affected384 at risk EG0022 events2 affected384 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0024 events3 affected384 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0022 events2 affected384 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0023 events2 affected384 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0012 events1 affected384 at risk EG0023 events2 affected384 at risk EG003
Seizure	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0023 events2 affected384 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment		EG0001 events1 affected47 at risk EG0011 events1 affected384 at risk EG0024 events4 affected384 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0016 events5 affected384 at risk EG00211 events10 affected384 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0012 events2 affected384 at risk EG0022 events2 affected384 at risk EG003
Hypotension	Vascular disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0012 events2 affected384 at risk EG0023 events3 affected384 at risk EG003
Shock	Vascular disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0012 events2 affected384 at risk EG0022 events2 affected384 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0022 events2 affected384 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0002 events1 affected47 at risk EG0010 events0 affected384 at risk EG0024 events4 affected384 at risk EG003
Plaque shift	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0001 events1 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0023 events3 affected384 at risk EG003
Acute left ventricular failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0022 events1 affected384 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0022 events1 affected384 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Gastric disorder	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Asthenia	General disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Drug withdrawal syndrome	General disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0022 events2 affected384 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Infection	Infections and infestations	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG00215 events14 affected384 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Gastroenteritis Escherichia coli	Infections and infestations	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0025 events5 affected384 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0022 events1 affected384 at risk EG003
Vascular access site complication	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Vascular access site haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Ejection fraction decreased	Investigations	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0022 events1 affected384 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Presyncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0025 events5 affected384 at risk EG003
Syncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0024 events4 affected384 at risk EG003
Aphasia	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Drug withdrawal convulsions	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Spinal claudication	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Bladder outlet obstruction	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0011 events1 affected384 at risk EG0021 events1 affected384 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0026 events5 affected384 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0023 events3 affected384 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0022 events2 affected384 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0022 events1 affected384 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Hospitalisation	Surgical and medical procedures	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0024 events4 affected384 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0022 events2 affected384 at risk EG003
Aortic dissection	Vascular disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Embolism	Vascular disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Intermittent claudication	Vascular disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0021 events1 affected384 at risk EG003
Nomocytic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Goitre	Endocrine disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Pancreatic cyst	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Pancreatic mass	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Vascular stent thrombosis	General disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Corona virus infection	Infections and infestations	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Enterococcal bacteraemia	Infections and infestations	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Transfusion-related circulatory overload	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Liver function test abnormal	Investigations	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Eccrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Brain injury	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Cervical radiculopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Lacunar stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Trigeminal neuralgia	Nervous system disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected47 at risk EG0010 events0 affected384 at risk EG0020 events0 affected384 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Myocardial necrosis marker increased (elevated cardiac biomarker)	Investigations	MedDRA 21.1	Systematic Assessment	Cardiac biomarker includes troponin or CK-MB	EG00012 events10 affected47 at risk EG00160 events54 affected384 at risk EG00264 events57 affected384 at risk EG00366 events58 affected384 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.1	Systematic Assessment	Pivotal group through 30 days does not meet 5% frequency threshold for reporting	EG0003 events3 affected47 at risk EG00118 events17 affected384 at risk EG00240 events37 affected384 at risk EG003
Coronary artery dissection	Cardiac disorders	MedDRA 21.1	Systematic Assessment	Pivotal group does not meet 5% frequency threshold for reporting	EG0003 events3 affected47 at risk EG00118 events18 affected384 at risk EG00218 events18 affected384 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	Roll-in and pivotal groups through 30 days do not meet 5% frequency threshold for reporting	EG0000 events0 affected47 at risk EG00118 events16 affected384 at risk EG00238 events32 affected384 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	Roll-in and pivotal groups through 30 days do not meet 5% frequency threshold for reporting	EG0000 events0 affected47 at risk EG0018 events7 affected384 at risk EG00226 events25 affected384 at risk EG003
Infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	Roll-in and pivotal groups through 30 days do not meet 5% frequency threshold for reporting	EG0001 events1 affected47 at risk EG0011 events1 affected384 at risk EG00227 events25 affected384 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 21.1	Systematic Assessment	Roll-in and pivotal groups through 30 days and 12 months do not meet 5% frequency threshold for reporting	EG0000 events0 affected47 at risk EG00111 events10 affected384 at risk EG00221 events19 affected384 at risk EG003
Fatigue	General disorders	MedDRA 21.1	Systematic Assessment	Roll-in and pivotal groups through 30 days and 12 months do not meet 5% frequency threshold for reporting	EG0002 events2 affected47 at risk EG0014 events4 affected384 at risk EG00214 events14 affected384 at risk EG003

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis

ID	Term
D013812	Therapeutics
D059708	Ultrasonic Surgical Procedures
D013514	Surgical Procedures, Operative

ID	Title	Description
BG000	Coronary IVL System (Roll-In)	The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30 days, at which time subject participation was complete.
BG001	Coronary IVL System (Pivotal)	The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Coronary IVL System (Roll-In) Through 30 Days	Adverse events reported through 30 days post-procedure for Roll-In subjects. The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30 days, at which time subject participation was complete.	0	47	4	47	15	47
EG001	Coronary IVL System (Pivotal) Through 30 Days	Adverse events reported through 30 days post-procedure for Pivotal subjects. The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints.	2	384	54	384	54	384
EG002	Coronary IVL System (Pivotal) Through 12 Months	Adverse events reported through 12 months post-procedure for Pivotal subjects. Adverse event data on pivotal subjects was collected through 12 months for long-term follow-up.	7	384	136	384	140	384
EG003	Coronary IVL System (Pivotal) Through 24 Months	Adverse events reported through 24 months post-procedure for Pivotal subjects. Adverse event data on pivotal subjects was collected through 24 months for long-term follow-up.	22	384	173	384	162	384