CompletedNCT03595176Updated May 19, 2023Results posted

Disrupt CAD III With the Shockwave Coronary IVL System

An interventional study of Lithotripsy in Coronary Artery Disease and Myocardial Infarction, sponsored by Shockwave Medical, Inc.. Completed at 48 sites in 4 countries. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by Shockwave Medical, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 431
Allocation: Not applicable
Sex: All

Study summary

The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.

Read the detailed description

Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI). Approximately 392 subjects at 50 sites will be enrolled. A minimum of 50% of the total enrollment will come from the United States.Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.

Conditions studied

Coronary Artery Disease
Myocardial Infarction

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Keywords

Intravascular Lithotripsy
Percutaneous Coronary Intervention

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 431 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Shockwave Medical, Inc. is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 431 participants (actual)

Study arms

Experimental
Coronary Lithotripsy System
All subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System
Device: Lithotripsy

Interventions

DeviceLithotripsy
Deliver Lithotripsy to the target vessel prior to placing a coronary stent.

What researchers measure

Primary outcomes

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

Secondary outcomes

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.
Time frame: at end of procedure
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.
Time frame: at end of procedure
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.
Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
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.
Time frame: at end of procedure
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.
Time frame: at end of procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
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.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
All-Cause Death Rate at 30 Days
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
Cardiac Death Rate at 30 Days
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
MI Rate at 30 Days
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
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.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
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.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
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.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
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.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
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.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
Non-ID-TVR Rate at 30 Days
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
Non-ID-TLR Rate at 30 Days
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
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.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
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.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
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.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure
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.
Time frame: within 30 days of index procedure
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.
Time frame: within 6 months of index procedure
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.
Time frame: within 12 months of index procedure
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.
Time frame: within 24 months of index procedure

Results

Posted Jun 21, 2021

Participant flow

Study recruitment and enrollment took place at 47 global centers including 38 in the United States and 9 in Europe between January 9, 2019 and March 27, 2020. A total of 431 subjects with de novo, calcified, stenotic, coronary arteries were enrolled and treated with the Coronary Intravascular Lithotripsy (IVL) System.

Participant flow — Overall Study
Milestone	Coronary IVL System (Roll-In)	Coronary IVL System (Pivotal)
Started	47	384
Completed	47	381
Not completed	0	3
Withdrew: Death	0	2
Withdrew: Lost to follow-up	0	1

Outcome measures

PrimaryNumber 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.

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure
percentage of participants	Coronary IVL System (Pivotal)
Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure	92.2 (89.9 to NA)

PrimaryNumber 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.

Time frame:: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
Reported as:: Number · percentage of participants

Number of Participants With Procedural Success (Residual Stenosis <50%)
percentage of participants	Coronary IVL System (Pivotal)
Number of Participants With Procedural Success (Residual Stenosis <50%)	92.4 (90.2 to NA)

SecondaryNumber 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.

Time frame:: at end of procedure
Reported as:: Count of participants · Participants

Number of Participants With Device Crossing Success
Participants	Coronary IVL System (Pivotal)
Number of Participants With Device Crossing Success	368

SecondaryNumber 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.

Time frame:: at end of procedure
Reported as:: Count of participants · Participants

Number of Participants With Angiographic Success (Residual Stenosis <50%)
Participants	Coronary IVL System (Pivotal)
Number of Participants With Angiographic Success (Residual Stenosis <50%)	370

SecondaryNumber 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.

Time frame:: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
Reported as:: Count of participants · Participants

Number of Participants With Procedural Success (Residual Stenosis <=30%)
Participants	Coronary IVL System (Pivotal)
Number of Participants With Procedural Success (Residual Stenosis <=30%)	354

SecondaryNumber 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.

Time frame:: at end of procedure
Reported as:: Count of participants · Participants

Number of Participants With Angiographic Success (Residual Stenosis <=30%)
Participants	Coronary IVL System (Pivotal)
Number of Participants With Angiographic Success (Residual Stenosis <=30%)	369

SecondaryNumber 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.

Time frame:: at end of procedure
Reported as:: Count of participants · Participants

Number of Participants With Serious Angiographic Complications
Participants	Coronary IVL System (Pivotal)
Number of Participants With Serious Angiographic Complications	12

SecondaryMACE 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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

MACE Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
MACE Rate at 6 Months	10.2

SecondaryMACE 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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

MACE Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
MACE Rate at 12 Months	13.6

SecondaryMACE 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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

MACE Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
MACE Rate at 24 Months	18.9

SecondaryTarget 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.

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Target Lesion Failure (TLF) Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Target Lesion Failure (TLF) Rate at 30 Days	7.6

SecondaryTarget 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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

Target Lesion Failure (TLF) Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
Target Lesion Failure (TLF) Rate at 6 Months	9.1

SecondaryTarget 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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

Target Lesion Failure (TLF) Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
Target Lesion Failure (TLF) Rate at 12 Months	11.9

SecondaryTarget 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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

Target Lesion Failure (TLF) Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
Target Lesion Failure (TLF) Rate at 24 Months	16.1

SecondaryAll-Cause Death Rate at 30 Days

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

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

All-Cause Death Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
All-Cause Death Rate at 30 Days	0.5

SecondaryAll-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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

All-Cause Death Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
All-Cause Death Rate at 6 Months	1.3

SecondaryAll-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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

All-Cause Death Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
All-Cause Death Rate at 12 Months	1.8

SecondaryAll-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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

All-Cause Death Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
All-Cause Death Rate at 24 Months	5.9

SecondaryCardiac Death Rate at 30 Days

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

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Cardiac Death Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Cardiac Death Rate at 30 Days	0.5

SecondaryCardiac 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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

Cardiac Death Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
Cardiac Death Rate at 6 Months	0.8

SecondaryCardiac 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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

Cardiac Death Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
Cardiac Death Rate at 12 Months	1.1

SecondaryCardiac 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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

Cardiac Death Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
Cardiac Death Rate at 24 Months	2.7

SecondaryMI Rate at 30 Days

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

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

MI Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
MI Rate at 30 Days	7.3

SecondaryMI 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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

MI Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
MI Rate at 6 Months	9.1

SecondaryMI 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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

MI Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
MI Rate at 12 Months	10.5

SecondaryMI 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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

MI Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
MI Rate at 24 Months	12.6

SecondaryTarget 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.

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Target Vessel-Myocardial Infarction (TV-MI) Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Target Vessel-Myocardial Infarction (TV-MI) Rate at 30 Days	7.3

SecondaryTV-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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

TV-MI Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
TV-MI Rate at 6 Months	7.6

SecondaryTV-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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

TV-MI Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
TV-MI Rate at 12 Months	7.8

SecondaryTV-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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

TV-MI Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
TV-MI Rate at 24 Months	8.1

SecondaryProcedural 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.

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Procedural MI Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Procedural MI Rate at 30 Days	6.8

SecondaryProcedural 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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

Procedural MI Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
Procedural MI Rate at 6 Months	6.8

SecondaryProcedural 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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

Procedural MI Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
Procedural MI Rate at 12 Months	6.8

SecondaryProcedural 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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

Procedural MI Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
Procedural MI Rate at 24 Months	6.8

SecondaryNon-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.

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Non-Procedural MI Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Non-Procedural MI Rate at 30 Days	1.0

SecondaryNon-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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

Non-Procedural MI Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
Non-Procedural MI Rate at 6 Months	3.2

SecondaryNon-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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

Non-Procedural MI Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
Non-Procedural MI Rate at 12 Months	4.8

SecondaryNon-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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

Non-Procedural MI Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
Non-Procedural MI Rate at 24 Months	7.2

SecondaryIschemia-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.

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Ischemia-Driven Target Vessel Revascularization (ID-TVR) Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Ischemia-Driven Target Vessel Revascularization (ID-TVR) Rate at 30 Days	1.6

SecondaryID-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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

ID-TVR Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
ID-TVR Rate at 6 Months	2.9

SecondaryID-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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

ID-TVR Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
ID-TVR Rate at 12 Months	6.0

SecondaryID-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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

ID-TVR Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
ID-TVR Rate at 24 Months	8.5

SecondaryIschemia-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.

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days	1.3

SecondaryID-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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

ID-TLR Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
ID-TLR Rate at 6 Months	2.4

SecondaryID-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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

ID-TLR Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
ID-TLR Rate at 12 Months	4.3

SecondaryID-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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

ID-TLR Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
ID-TLR Rate at 24 Months	6.4

SecondaryNon-ID-TVR Rate at 30 Days

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

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Non-ID-TVR Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Non-ID-TVR Rate at 30 Days	0

SecondaryNon-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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

Non-ID-TVR Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
Non-ID-TVR Rate at 6 Months	0

SecondaryNon-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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

Non-ID-TVR Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
Non-ID-TVR Rate at 12 Months	0

SecondaryNon-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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

Non-ID-TVR Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
Non-ID-TVR Rate at 24 Months	0

SecondaryNon-ID-TLR Rate at 30 Days

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

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Non-ID-TLR Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Non-ID-TLR Rate at 30 Days	0

SecondaryNon-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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

Non-ID-TLR Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
Non-ID-TLR Rate at 6 Months	0

SecondaryNon-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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

Non-ID-TLR Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
Non-ID-TLR Rate at 12 Months	0

SecondaryNon-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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

Non-ID-TLR Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
Non-ID-TLR Rate at 24 Months	0

SecondaryAny 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.

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Any Revascularizations Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Any Revascularizations Rate at 30 Days	2.6

SecondaryAny 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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

Any Revascularizations Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
Any Revascularizations Rate at 6 Months	7.9

SecondaryAny 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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

Any Revascularizations Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
Any Revascularizations Rate at 12 Months	12.3

SecondaryAny 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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

Any Revascularizations Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
Any Revascularizations Rate at 24 Months	15.4

SecondaryStent 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.

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Stent Thrombosis Rate at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Stent Thrombosis Rate at 30 Days	0.8

SecondaryStent 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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

Stent Thrombosis Rate at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
Stent Thrombosis Rate at 6 Months	1.3

SecondaryStent 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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

Stent Thrombosis Rate at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
Stent Thrombosis Rate at 12 Months	1.6

SecondaryStent 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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

Stent Thrombosis Rate at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
Stent Thrombosis Rate at 24 Months	2.7

SecondaryRate 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.

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Rate of MI Using the 4th Universal Definition at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Rate of MI Using the 4th Universal Definition at 30 Days	7.3

SecondaryRate 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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

Rate of MI Using the 4th Universal Definition at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
Rate of MI Using the 4th Universal Definition at 6 Months	7.3

SecondaryRate 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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

Rate of MI Using the 4th Universal Definition at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
Rate of MI Using the 4th Universal Definition at 12 Months	7.3

SecondaryRate 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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

Rate of MI Using the 4th Universal Definition at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
Rate of MI Using the 4th Universal Definition at 24 Months	7.3

SecondaryRate 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.

Time frame:: within 30 days of index procedure
Reported as:: Number · percentage of participants

Rate of MI Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition at 30 Days
percentage of participants	Coronary IVL System (Pivotal)
Rate of MI Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition at 30 Days	2.6

SecondaryRate 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.

Time frame:: within 6 months of index procedure
Reported as:: Number · percentage of participants

Rate of MI Using the SCAI Definition at 6 Months
percentage of participants	Coronary IVL System (Pivotal)
Rate of MI Using the SCAI Definition at 6 Months	2.6

SecondaryRate 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.

Time frame:: within 12 months of index procedure
Reported as:: Number · percentage of participants

Rate of MI Using the SCAI Definition at 12 Months
percentage of participants	Coronary IVL System (Pivotal)
Rate of MI Using the SCAI Definition at 12 Months	2.6

SecondaryRate 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.

Time frame:: within 24 months of index procedure
Reported as:: Number · percentage of participants

Rate of MI Using the SCAI Definition at 24 Months
percentage of participants	Coronary IVL System (Pivotal)
Rate of MI Using the SCAI Definition at 24 Months	2.6

Adverse events

Collected over within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Coronary IVL System (Roll-In) Through 30 Days	0/47 (0%)	4/47 (8.5%)	15/47 (31.9%)
Coronary IVL System (Pivotal) Through 30 Days	2/384 (0.5%)	54/384 (14.1%)	54/384 (14.1%)
Coronary IVL System (Pivotal) Through 12 Months	7/384 (1.8%)	136/384 (35.4%)	140/384 (36.5%)
Coronary IVL System (Pivotal) Through 24 Months	22/384 (5.7%)	173/384 (45.1%)	162/384 (42.2%)

Most frequent serious events

Showing 10 of 167

Most frequent serious events
Event	Coronary IVL System (Roll-In) Through 30 Days	Coronary IVL System (Pivotal) Through 30 Days	Coronary IVL System (Pivotal) Through 12 Months	Coronary IVL System (Pivotal) Through 24 Months
Myocardial infarctionCardiac disorders	0/47	8/384	16/384	24/384
InfectionInfections and infestations	0/47	0/384	14/384	24/384
ArrhythmiaCardiac disorders	0/47	6/384	15/384	19/384
Angina pectorisCardiac disorders	0/47	5/384	15/384	17/384
Respiratory failureRespiratory, thoracic and mediastinal disorders	0/47	5/384	10/384	15/384
Coronary artery dissectionCardiac disorders	1/47	11/384	11/384	11/384
SepsisInfections and infestations	1/47	2/384	6/384	11/384
Non-cardiac chest painGeneral disorders	0/47	5/384	8/384	9/384
Coronary artery restenosisInjury, poisoning and procedural complications	0/47	0/384	5/384	9/384
Cardiac failure congestiveCardiac disorders	1/47	1/384	4/384	6/384

Most frequent other events

Most frequent other events
Event	Coronary IVL System (Roll-In) Through 30 Days	Coronary IVL System (Pivotal) Through 30 Days	Coronary IVL System (Pivotal) Through 12 Months	Coronary IVL System (Pivotal) Through 24 Months
Myocardial necrosis marker increased (elevated cardiac biomarker)Investigations	10/47	54/384	57/384	58/384
Angina pectorisCardiac disorders	3/47	17/384	37/384	43/384
DyspnoeaRespiratory, thoracic and mediastinal disorders	0/47	16/384	32/384	34/384
InfectionInfections and infestations	1/47	1/384	25/384	30/384
ArrhythmiaCardiac disorders	0/47	7/384	25/384	29/384
Coronary artery dissectionCardiac disorders	3/47	18/384	18/384	18/384
Non-cardiac chest painGeneral disorders	0/47	10/384	19/384	23/384
FatigueGeneral disorders	2/47	4/384	14/384	21/384

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Coronary IVL System (Roll-In)	Coronary IVL System (Pivotal)	Total
Mean	70.3 ± 7.6	71.2 ± 8.6	71.1 ± 8.5

Age, Customized
Age, Customized(years)	Coronary IVL System (Roll-In)	Coronary IVL System (Pivotal)	Total
Median (Q1, Q3)	72.0 (64.0 to 76.0)	71.0 (66.0 to 77.0)	71.0 (66.0 to 77.0)

Sex: Female, Male
Sex: Female, Male(Participants)	Coronary IVL System (Roll-In)	Coronary IVL System (Pivotal)	Total
Female	12	90	102
Male	35	294	329

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Coronary IVL System (Roll-In)	Coronary IVL System (Pivotal)	Total
Hispanic or Latino	1	16	17
Not Hispanic or Latino	41	330	371
Unknown or Not Reported	5	38	43

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Coronary IVL System (Roll-In)	Coronary IVL System (Pivotal)	Total
American Indian or Alaska Native	0	2	2
Asian	2	13	15
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	3	12	15
White	35	318	353
More than one race	0	0	0
Unknown or Not Reported	7	38	45

Region of Enrollment
Region of Enrollment(Participants)	Coronary IVL System (Roll-In)	Coronary IVL System (Pivotal)	Total
United States	38	335	373
Europe	9	49	58

Study locations

48 sites

Honor Health
Scottsdale, Arizona 85258, United States
Scripps Clinic
La Jolla, California 92037, United States
University of California, San Diego (UCSD) - Medical Center
La Jolla, California 92037, United States
St. Joseph Hospital
Orange, California 92868, United States
VA Palo Alto Health Care System
Palo Alto, California 94304, United States
Yale New Haven Hospital
New Haven, Connecticut 06520, United States
MedStar Washington Hospital Center
Washington, District of Columbia 20010, United States
Emory University Hospital Midtown
Atlanta, Georgia 30308, United States
Piedmont Heart Institute
Atlanta, Georgia 30309, United States
Northwestern University
Chicago, Illinois 60611, United States
Advocate Health and Hospitals Corporation - Edward Hospital
Oakbrook Terrace, Illinois 60540, United States
St. Vincent Heart Center of Indiana, LLC
Indianapolis, Indiana 46290, United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70121, United States
MedStar Union Memorial Hospital
Baltimore, Maryland 21218, United States
Massachusetts General Hospital
Boston, Massachusetts 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215, United States
Henry Ford Hospital
Detroit, Michigan 48202, United States
Minneapolis Heart Institute
Minneapolis, Minnesota 55407, United States
North Mississippi Medical Center
Tupelo, Mississippi 38801, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey 08015, United States
Montefiore Medical Center
Bronx, New York 10467, United States
New York University (NYU) Langone Medical Center
New York, New York 10016, United States
Columbia University Medical Center/ New York Presbyterian
New York, New York 10065, United States
St. Francis Hospital
Roslyn, New York 11576, United States
Durham VA Health Care System
Durham, North Carolina 27705, United States
NC Heart and Vascular
Raleigh, North Carolina 27607, United States
The Christ Hospital
Cincinnati, Ohio 45219, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19096, United States
Geisinger Medical Center
Danville, Pennsylvania 17822, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213, United States
Pinnacle Health Cardiovascular Institute Inc.
Wormleysburg, Pennsylvania 17043, United States
The Miriam Hospital
Providence, Rhode Island 02906, United States
Baylor Heart and Vascular Hospital
Dallas, Texas 75226, United States
Houston Methodist Hospital
Houston, Texas 77030, United States
University of Vermont
Burlington, Vermont 05401, United States
University of Washington Medical Center
Seattle, Washington 98195, United States
Charleston Area Medical Center (CAMC) - Health Education & Research Institute
Charleston, West Virginia 25304, United States
Clinique Pasteur
Toulouse, Cedex 3 31076, France
Clinique des Domes - Pole Sante Republique
Clermont-Ferrand, 63050, France
Institute Cardiovasculaire Paris Sud
Massy, 91300, France
Universitaetsklinikum Giessen and Marburg GmbH
Marburg, CET, Germany
Charité - Universitaetsmedizin Berlin
Berlin, 12203, Germany
Rheinland Klinikum Neuss GmbH - Lukaskrankenhaus Neuss
Neuss, 41464, Germany
Golden Jubilee National Hospital
Clydebank, G81 4DY, United Kingdom
St. Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom

References and documents

Publications

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. PubMed 33069849 ↗
Kereiakes DJ, Hill JM, Ben-Yehuda O, Maehara A, Alexander B, Stone GW. Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial. Am Heart J. 2020 Jul;225:10-18. doi: 10.1016/j.ahj.2020.04.005. Epub 2020 Apr 18. PubMed 32470635 ↗
Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3. PubMed 33939604 ↗

Study documents

Protocol and statistical analysis plan · Mar 5, 2021

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03595176
Lead sponsor: Shockwave Medical, Inc.
Responsible party: Sponsor
First posted: Jul 23, 2018
Start date: Jan 9, 2019
Primary completion: May 7, 2020
Completion: Apr 10, 2022
Results posted: Jun 21, 2021
Last update: May 19, 2023

Study contacts

Dean J Kereiakes, MD,FACC,FSCAI

study chair · The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital

Gregg W Stone, MD,FACC,FSCAI

study chair · Columbia University

Jonathan Hill, MD

study chair · Royal Brompton and Harefield NHS Foundation Trust

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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Disrupt CAD III With the Shockwave Coronary IVL System

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