Coronary Artery Disease, Myocardial Infarction
Conditions
Keywords
Intravascular Lithotripsy, Percutaneous Coronary Intervention
Brief summary
The study design is a prospective, multicenter, single-arm 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.
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. Approximately 72 subjects at 8 sites in Japan will be enrolled. Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.
Interventions
DEVICELithotripsy
Deliver Lithotripsy to the target vessel prior to placing a coronary stent
Sponsors
Shockwave Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The Coronary IVL System is a proprietary balloon catheter system designed to enhance stent outcomes by enabling delivering of the calcium disrupting capability of lithotripsy prior to balloon dilatation at low pressures. The Coronary IVL System consists of an IVL Balloon Catheter with 2 integrated emitters, a Lithotripsy Generator, and a Connector Cable.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥18 years of age 2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI 3. 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) 4. 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 prior to the index 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. 5. 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) 6. Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures 7. 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 8. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure 9. 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 10. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm 11. The lesion length must not exceed 40 mm 12. The target vessel must have TIMI flow 3 at baseline (visually assessed, may be assessed after pre-dilatation) 13. 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 14. Ability to pass a 0.014 guide wire across the lesion
Exclusion criteria
1. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits 2. Subject is a member of a vulnerable population 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. 3. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint 4. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment) 5. Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months 6. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated 7. 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 8. New York Heart Association (NYHA) class III or IV heart failure 9. Renal failure with serum creatinine \>2.5 mg/dL, or chronic dialysis 10. History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit 11. Active peptic ulcer or upper gastrointestinal (GI) b≥leeding within 6 months 12. Untreated pre-procedural hemoglobin \<10 g/dL or intention to refuse blood transfusions if one should become necessary 13. 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) 14. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count \>750,000 or other disorders 15. Uncontrolled diabetes defined as a HbA1c ≥10% 16. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics 17. Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia) 18. Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg) 19. Subjects with a life expectancy of less than 1 year 20. Non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days prior to the index procedure 21. Planned non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days after the index procedure 22. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery 23. Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy 24. Unprotected left main diameter stenosis \>30% 25. Target vessel is excessively tortuous defined as the presence of two or more bends \>90º or three or more bends \>75º 26. Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel 27. Evidence of aneurysm in target vessel within 10 mm of the target lesion 28. Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion 29. Target lesion is a bifurcation with ostial diameter stenosis ≥30% 30. Second lesion with \>50% stenosis in the same target vessel as the target lesion including its side branches 31. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft 32. Previous stent within the target vessel implanted within the last year 33. Previous stent within 10 mm of the target lesion regardless of the timing of its implantation 34. Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure | Within 30 days of index procedure | The primary safety endpoint was freedom from major adverse cardiac events (MACE) at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Intent To Treat (ITT) population. |
| Percentage of Subjects With Procedural Success | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedural Success (Residual Stenosis <=30%) | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure | secondary endpoint was Procedural Success defined as stent delivery with aresidual stenosis \<=30% (core laboratory assessed) and without in-hospital MACE. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Stent Thrombosis at 12 Months | within 12 months of index procedure | Stent thrombosis is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Number of Participants With Angiographic Success (Residual Stenosis <=30%) | At end of procedure, with a mean total procedure time of 62.5 minutes | A secondary endpoint was Angiographic Success defined as stent delivery with\<=30% residual stenosis and without serious angiographic complications. These secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Number of Participants With Serious Angiographic Complications | At end of procedure, with a mean total procedure time of 62.5 minutes | A secondary endpoint was Serious Angiographic Complications defined as severedissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| MACE Rate at 6 Months | within 6 months of index procedure | The MACE rate at 6 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)- is presented as Kaplan-Meier (K-M) estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| MACE Rate at 12 Months | within 12 months of index procedure | The MACE rate at 12 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)- is presented as Kaplan-Meier (K-M) estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| MACE Rate at 24 Months | within 24 months of index procedure | The MACE rate at 24 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)- is presented as Kaplan-Meier (K-M) estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Target Lesion Failure (TLF) at 30 Days | Within 30 days of index procedure | Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR), and is presented as proportions at 30 days. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Target Lesion Failure (TLF) at 6 Months | Within 6 months of index procedure | Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR). TLF is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Target Lesion Failure (TLF) at 12 Months | Within 12 months of index procedure | Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR). TLF is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Target Lesion Failure (TLF) at 24 Months | Within 24 months of index procedure | Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR). TLF is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| All-Cause Death at 30 Days | Within 30 days from index procedure | The 30-day rates of all-cause death are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| All-Cause Death at 6 Months | within 6 months of index procedure | All-cause death at 6 months is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| All-Cause Death at 12 Months | within 12 months of procedure | All-cause death at 12 month is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| All-Cause Death at 24 Months | within 24 months of procedure | All-cause death at 24 month is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction (MI) at 30 Days | within 30 days of index procedure | The 30-day MI rates are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction (MI) at 6 Months | Within 6 months of index procedure | MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction (MI) at 12 Months | Within 12 months of index procedure | MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction (MI) at 24 Months | Within 24 months of index procedure | MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction Attributable to Target Vessel (TV-MI) at 30 Days | within 30 days of index procedure | The Myocardial Infarction attributable to the target vessel (TV-MI) rates at 30 days are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction Attributable to Target Vessel (TV-MI) at 6 Months | Within 6 month of index procedure | The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction Attributable to Target Vessel (TV-MI) at 12 Months | Within 12 months of index procedure | The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction Attributable to Target Vessel (TV-MI) at 24 Months | Within 24 months of index procedure | The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Stent Thrombosis at 30 Days | Within 30 days of index procedure | The Stent Thrombosis rate at 30 days is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Stent Thrombosis at 6 Months | within 6 months of index procedure | Stent thrombosis is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Stent Thrombosis at 24 Months | within 24 months of index procedure | Stent thrombosis is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| All Revascularizations at 30 Days | within 30 days of index procedure | The 30-day revascularization rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| All Revascularizations at 6 Months | within 6 months of index procedure | All revascularizations are presented as Kaplan-Meier estimated event rates at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| All Revascularizations at 12 Months | within 12 months of index procedure | All revascularizations are presented as Kaplan-Meier estimated event rates at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| All Revascularizations at 24 Months | within 24 months of index procedure | All revascularizations are presented as Kaplan-Meier estimated event rates at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 30 Days | within 30 days of index procedure | The ischemia-driven Target Vessel Revascularization at 30 days is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 6 Months | within 6 months of index procedure | The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Ischemia-driven Target Vessel Revascularization (ID-TVR) at 12 Months | within 12 months of index procedure | The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Ischemia-driven Target Vessel Revascularization (ID-TVR) at 24 Months | within 24 months of index procedure | The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 30 Days | within 30 days of index procedure | The ischemia-driven Target Lesion Revascularization (ID-TLR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 6 Months | within 6 months of index procedure | The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 12 Months | within 12 months of index procedure | The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 24 Months | within 24 months of index procedure | The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 30 Days | within 30 days of index procedure | The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 6 Months | within 6 months of index procedure | The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 12 Months | within 12 months of index procedure | The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 24 Months | within 24 months of index procedure | The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 30 Days | within 30 days of index procedure | The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 6 Months | within 6 months of index procedure | The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 12 Months | within 12 months of index procedure | The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 24 Months | within 24 months of index procedure | The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Procedural MI at 30 Days | within 30 days of index procedure | The procedural MI 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Procedural MI at 6 Months | within 6 months of index procedure | The procedural MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Procedural MI at 12 Months | within 12 months of index procedure | The procedural MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Procedural MI at 24 Months | within 24 months of index procedure | The procedural MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Non-Procedural MI at 30 Days | within 30 days of index procedure | The non-procedural MI 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Non-Procedural MI at 6 Months | within 6 months of index procedure | The non-procedural MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Non-Procedural MI at 12 Months | within 12 months of index procedure | The non-procedural MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Non-Procedural MI at 24 Months | within 24 months of index procedure | The non-procedural MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 30 Days | within 30 days of index procedure | The 30-day rate of MI using the Fourth Universal Definition of MI is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Number of Participants With Device Crossing Success | At end of procedure, with a mean total procedure time of 62.5 minutes | A secondary endpoint was 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 Intent To Treat Analysis Set. |
| Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 12 Months | within 12 months of index procedure | MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 24 Months | within 24 months of index procedure | MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 30 Days | within 30 days of index procedure | The 30-day rate of MI using the SCAI Definition of MI is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 6 Months | within 6 months of index procedure | MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 12 Months | within 12 months of index procedure | MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 24 Months | within 24 months of index procedure | MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 6 Months | within 6 months of index procedure | MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
| Number of Participants With Angiographic Success (Residual Stenosis <50%) | At end of procedure, with a mean total procedure time of 62.5 minutes | A secondary endpoint was Angiographic Success defined as stent delivery with \<50%residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. |
Countries
Japan
Participant flow
Recruitment details
Study enrollment took place at 8 study centers in Japan between November 6, 2019 and April 6, 2020. A total of 72 subjects with de novo, calcified, stenotic coronary arteries were enrolled and treated with the Coronary Intravascular Lithotripsy (IVL) System
Pre-assignment details
72 subjects were consented and enrolled into the study
Participants by arm
| Arm | Count |
|---|---|
| Roll-in The first subject enrolled at each site is considered a roll-in. Data on roll-in subjects were collected through 30 days, at which time subject participation was complete. | 8 |
| Intent to Treat (ITT) The Intent to Treat (ITT) population was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on the ITT population was collected through 30 days for primary endpoints. Long-term follow-up for the ITT population to 24 months is complete. | 64 |
| Total | 72 |
Baseline characteristics
| Characteristic | Roll-in | Intent to Treat (ITT) | Total |
|---|---|---|---|
| Age, Continuous | 73.3 years STANDARD_DEVIATION 3.5 | 75.0 years STANDARD_DEVIATION 8 | 74.8 years STANDARD_DEVIATION 7.7 |
| Age, Customized | 72.5 years | 74.5 years | 73.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 64 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 63 Participants | 71 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 8 participants | 64 participants | 72 participants |
| Sex: Female, Male Female | 2 Participants | 16 Participants | 18 Participants |
| Sex: Female, Male Male | 6 Participants | 48 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 64 | 0 / 64 | 2 / 64 |
| other Total, other adverse events | 1 / 8 | 11 / 64 | 14 / 64 | 14 / 64 |
| serious Total, serious adverse events | 0 / 8 | 5 / 64 | 23 / 64 | 30 / 64 |
Outcome results
Primary
Percentage of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure
The primary safety endpoint was freedom from major adverse cardiac events (MACE) at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Intent To Treat (ITT) population.
Time frame: Within 30 days of index procedure
Population: ITT population was the primary analysis cohort; data on roll-in subjects was only collected through 30 days. Data collected from the roll-in subjects were not pre-specified to be reported as a Primary or Secondary Outcome Measure; therefore, only the ITT arm is reported. The ITT population includes all subjects enrolled in the pivotal phase of the study. This population does not include roll-in subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Percentage of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure | 93.8 percentage of participants |
Primary
Percentage of Subjects With Procedural Success
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
Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
Population: ITT population was the primary analysis cohort; data on roll-in subjects was only collected through 30 days. Data collected from the roll-in subjects were not pre-specified to be reported as a Primary or Secondary Outcome Measure; therefore, only the ITT arm is reported. The ITT population includes all subjects enrolled in the pivotal phase of the study. This population does not include roll-in subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Percentage of Subjects With Procedural Success | 93.8 percentage of participants |
Secondary
All-Cause Death at 12 Months
All-cause death at 12 month is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 12 months of procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | All-Cause Death at 12 Months | 0 percentage of participants |
Secondary
All-Cause Death at 24 Months
All-cause death at 24 month is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 24 months of procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | All-Cause Death at 24 Months | 3.1 percentage of participants |
Secondary
All-Cause Death at 30 Days
The 30-day rates of all-cause death are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: Within 30 days from index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | All-Cause Death at 30 Days | 0 percentage of participants |
Secondary
All-Cause Death at 6 Months
All-cause death at 6 months is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | All-Cause Death at 6 Months | 0 percentage of participants |
Secondary
All Revascularizations at 12 Months
All revascularizations are presented as Kaplan-Meier estimated event rates at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | All Revascularizations at 12 Months | 15.6 percentage of participants |
Secondary
All Revascularizations at 24 Months
All revascularizations are presented as Kaplan-Meier estimated event rates at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | All Revascularizations at 24 Months | 20.4 percentage of participants |
Secondary
All Revascularizations at 30 Days
The 30-day revascularization rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | All Revascularizations at 30 Days | 0 percentage of participants |
Secondary
All Revascularizations at 6 Months
All revascularizations are presented as Kaplan-Meier estimated event rates at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | All Revascularizations at 6 Months | 12.5 percentage of participants |
Secondary
Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 12 Months
The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 12 Months | 1.6 percentage of participants |
Secondary
Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 24 Months
The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 24 Months | 3.2 percentage of participants |
Secondary
Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 30 Days
The ischemia-driven Target Lesion Revascularization (ID-TLR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 30 Days | 0 percentage of participants |
Secondary
Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 6 Months
The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 6 Months | 1.6 percentage of participants |
Secondary
Ischemia-driven Target Vessel Revascularization (ID-TVR) at 12 Months
The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Ischemia-driven Target Vessel Revascularization (ID-TVR) at 12 Months | 4.7 percentage of participants |
Secondary
Ischemia-driven Target Vessel Revascularization (ID-TVR) at 24 Months
The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Ischemia-driven Target Vessel Revascularization (ID-TVR) at 24 Months | 7.9 percentage of participants |
Secondary
Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 30 Days
The ischemia-driven Target Vessel Revascularization at 30 days is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 30 Days | 0 percentage of participants |
Secondary
Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 6 Months
The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 6 Months | 3.1 percentage of participants |
Secondary
MACE Rate at 12 Months
The MACE rate at 12 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)- is presented as Kaplan-Meier (K-M) estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | MACE Rate at 12 Months | 9.4 percentage of participants |
Secondary
MACE Rate at 24 Months
The MACE rate at 24 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)- is presented as Kaplan-Meier (K-M) estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | MACE Rate at 24 Months | 12.6 percentage of participants |
Secondary
MACE Rate at 6 Months
The MACE rate at 6 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)- is presented as Kaplan-Meier (K-M) estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | MACE Rate at 6 Months | 7.8 percentage of participants |
Secondary
Myocardial Infarction Attributable to Target Vessel (TV-MI) at 12 Months
The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: Within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction Attributable to Target Vessel (TV-MI) at 12 Months | 6.3 percentage of participants |
Secondary
Myocardial Infarction Attributable to Target Vessel (TV-MI) at 24 Months
The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: Within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction Attributable to Target Vessel (TV-MI) at 24 Months | 6.3 percentage of participants |
Secondary
Myocardial Infarction Attributable to Target Vessel (TV-MI) at 30 Days
The Myocardial Infarction attributable to the target vessel (TV-MI) rates at 30 days are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction Attributable to Target Vessel (TV-MI) at 30 Days | 6.3 percentage of participants |
Secondary
Myocardial Infarction Attributable to Target Vessel (TV-MI) at 6 Months
The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: Within 6 month of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction Attributable to Target Vessel (TV-MI) at 6 Months | 6.3 percentage of participants |
Secondary
Myocardial Infarction (MI) at 12 Months
MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: Within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction (MI) at 12 Months | 6.3 percentage of participants |
Secondary
Myocardial Infarction (MI) at 24 Months
MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: Within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction (MI) at 24 Months | 6.3 percentage of participants |
Secondary
Myocardial Infarction (MI) at 30 Days
The 30-day MI rates are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction (MI) at 30 Days | 6.3 percentage of participants |
Secondary
Myocardial Infarction (MI) at 6 Months
MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: Within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction (MI) at 6 Months | 6.3 percentage of participants |
Secondary
Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 12 Months
MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 12 Months | 7.8 percentage of participants |
Secondary
Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 24 Months
MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 24 Months | 7.8 percentage of participants |
Secondary
Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 30 Days
The 30-day rate of MI using the Fourth Universal Definition of MI is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 30 Days | 7.8 percentage of participants |
Secondary
Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 6 Months
MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 6 Months | 7.8 percentage of participants |
Secondary
Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 12 Months
MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 12 Months | 3.1 percentage of participants |
Secondary
Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 24 Months
MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 24 Months | 3.1 percentage of participants |
Secondary
Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 30 Days
The 30-day rate of MI using the SCAI Definition of MI is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 30 Days | 3.1 percentage of participants |
Secondary
Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 6 Months
MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 6 Months | 3.1 percentage of participants |
Secondary
Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 12 Months
The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 12 Months | 0 percentage of participants |
Secondary
Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 24 Months
The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 24 Months | 0 percentage of participants |
Secondary
Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 30 Days
The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 30 Days | 0 percentage of participants |
Secondary
Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 6 Months
The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 6 Months | 0 percentage of participants |
Secondary
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 12 Months
The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 12 Months | 0 percentage of participants |
Secondary
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 24 Months
The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 24 Months | 0 percentage of participants |
Secondary
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 30 Days
The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 30 Days | 0 percentage of participants |
Secondary
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 6 Months
The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 6 Months | 0 percentage of participants |
Secondary
Non-Procedural MI at 12 Months
The non-procedural MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Non-Procedural MI at 12 Months | 0 percentage of participants |
Secondary
Non-Procedural MI at 24 Months
The non-procedural MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Non-Procedural MI at 24 Months | 0 percentage of participants |
Secondary
Non-Procedural MI at 30 Days
The non-procedural MI 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Non-Procedural MI at 30 Days | 0 percentage of participants |
Secondary
Non-Procedural MI at 6 Months
The non-procedural MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Non-Procedural MI at 6 Months | 0 percentage of participants |
Secondary
Number of Participants With Angiographic Success (Residual Stenosis <=30%)
A secondary endpoint was Angiographic Success defined as stent delivery with\<=30% residual stenosis and without serious angiographic complications. These secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: At end of procedure, with a mean total procedure time of 62.5 minutes
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intent To Treat | Number of Participants With Angiographic Success (Residual Stenosis <=30%) | 63 Participants |
Secondary
Number of Participants With Angiographic Success (Residual Stenosis <50%)
A secondary endpoint was Angiographic Success defined as stent delivery with \<50%residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: At end of procedure, with a mean total procedure time of 62.5 minutes
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intent To Treat | Number of Participants With Angiographic Success (Residual Stenosis <50%) | 63 Participants |
Secondary
Number of Participants With Device Crossing Success
A secondary endpoint was 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 Intent To Treat Analysis Set.
Time frame: At end of procedure, with a mean total procedure time of 62.5 minutes
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat group is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intent To Treat | Number of Participants With Device Crossing Success | 63 Participants |
Secondary
Number of Participants With Procedural Success (Residual Stenosis <=30%)
secondary endpoint was Procedural Success defined as stent delivery with aresidual stenosis \<=30% (core laboratory assessed) and without in-hospital MACE. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intent To Treat | Number of Participants With Procedural Success (Residual Stenosis <=30%) | 60 Participants |
Secondary
Number of Participants With Serious Angiographic Complications
A secondary endpoint was Serious Angiographic Complications defined as severedissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: At end of procedure, with a mean total procedure time of 62.5 minutes
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intent To Treat | Number of Participants With Serious Angiographic Complications | 63 Participants |
Secondary
Procedural MI at 12 Months
The procedural MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Procedural MI at 12 Months | 6.3 percentage of participants |
Secondary
Procedural MI at 24 Months
The procedural MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Procedural MI at 24 Months | 6.3 percentage of participants |
Secondary
Procedural MI at 30 Days
The procedural MI 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Procedural MI at 30 Days | 6.3 percentage of participants |
Secondary
Procedural MI at 6 Months
The procedural MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Procedural MI at 6 Months | 6.3 percentage of participants |
Secondary
Stent Thrombosis at 12 Months
Stent thrombosis is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Stent Thrombosis at 12 Months | 0 percentage of participants |
Secondary
Stent Thrombosis at 24 Months
Stent thrombosis is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Stent Thrombosis at 24 Months | 0 percentage of participants |
Secondary
Stent Thrombosis at 30 Days
The Stent Thrombosis rate at 30 days is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: Within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Stent Thrombosis at 30 Days | 0 percentage of participants |
Secondary
Stent Thrombosis at 6 Months
Stent thrombosis is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Stent Thrombosis at 6 Months | 0 percentage of participants |
Secondary
Target Lesion Failure (TLF) at 12 Months
Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR). TLF is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: Within 12 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Target Lesion Failure (TLF) at 12 Months | 6.3 percentage of participants |
Secondary
Target Lesion Failure (TLF) at 24 Months
Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR). TLF is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: Within 24 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Target Lesion Failure (TLF) at 24 Months | 7.8 percentage of participants |
Secondary
Target Lesion Failure (TLF) at 30 Days
Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR), and is presented as proportions at 30 days. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: Within 30 days of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Target Lesion Failure (TLF) at 30 Days | 6.3 percentage of participants |
Secondary
Target Lesion Failure (TLF) at 6 Months
Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR). TLF is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
Time frame: Within 6 months of index procedure
Population: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent To Treat | Target Lesion Failure (TLF) at 6 Months | 6.3 percentage of participants |