Disrupt CAD IV With the Shockwave Coronary IVL System

Coronary Artery Disease Clinical Trial

Official title:

Prospective, Multicenter, Single-Arm Study of the SWM-1234 in Calcified Coronary Arteries (Disrupt CAD IV Study - Japan)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151628
• Other study ID #: CP 62611
• Status: Completed
• Phase: N/A
• Start date: November 6, 2019
• Est. completion date: March 25, 2022

Study information

• Verified date: April 2022
• Source: Shockwave Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 25, 2022
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Myocardial Infarction

Intervention

Device:
• Lithotripsy
Deliver Lithotripsy to the target vessel prior to placing a coronary stent

Locations

Country	Name	City	State
Japan	Shonan-Kamakura General Hospital	Kamakura	Kanagawa
Japan	Johas Kanto Rosai Hospital	Kawasaki	Kanagawa-Ken
Japan	Sakurakai Takahashi Hospital	Kobe	Hyogo-Ken
Japan	Tenjinkai Shin-Koga Hospital	Kurume	Fukuoka-Ken
Japan	Kyoto-Katsura Hospital	Kyoto-shi	Kyoto-Fu
Japan	Miyazaki Medical Association Hospital	Miyazaki	Miyazaki-Ken
Japan	Sapporo Higashi Tokushukai Hospital	Sapporo	Hokkaido
Japan	Higashi-Takarazuka Satoh Hospital	Takarazuka	Hyogo-Ken

Sponsors (1)

Lead Sponsor	Collaborator
Shockwave Medical, Inc.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Saito S, Yamazaki S, Takahashi A, Namiki A, Kawasaki T, Otsuji S, Nakamura S, Shibata Y; Disrupt CAD IV Investigators. Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent Placement - Primary Outcomes Fro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Within 30 days of index procedure
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	12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
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.	At end of procedure, with a mean total procedure time of 62.5 minutes
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.	At end of procedure, with a mean total procedure time of 62.5 minutes
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.	12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
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.	At end of procedure, with a mean total procedure time of 62.5 minutes
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.	At end of procedure, with a mean total procedure time of 62.5 minutes
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.	within 6 months of index procedure
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.	within 12 months of index procedure
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.	within 24 months of index procedure
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.	Within 30 days of index procedure
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.	Within 6 months of index procedure
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.	Within 12 months of index procedure
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.	Within 24 months of index procedure
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.	Within 30 days from index procedure
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.	within 6 months of index procedure
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.	within 12 months of procedure
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.	within 24 months of procedure
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.	within 30 days of index procedure
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.	Within 6 months of index procedure
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.	Within 12 months of index procedure
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.	Within 24 months of index procedure
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.	within 30 days of index procedure
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.	Within 6 month of index procedure
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.	Within 12 months of index procedure
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.	Within 24 months of index procedure
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.	Within 30 days of index procedure
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.	within 6 months of index procedure
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.	within 12 months of index procedure
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.	within 24 months of index procedure
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.	within 30 days of index procedure
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.	within 6 months of index procedure
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.	within 12 months of index procedure
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.	within 24 months of index procedure
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.	within 30 days of index procedure
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.	within 6 months of index procedure
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.	within 12 months of index procedure
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.	within 24 months of index procedure
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.	within 30 days of index procedure
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.	within 6 months of index procedure
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.	within 12 months of index procedure
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.	within 24 months of index procedure
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.	within 30 days of index procedure
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.	within 6 months of index procedure
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.	within 12 months of index procedure
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.	within 24 months of index procedure
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.	within 30 days of index procedure
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.	within 6 months of index procedure
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.	within 12 months of index procedure
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.	within 24 months of index procedure
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.	within 30 days of index procedure
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.	within 6 months of index procedure
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.	within 12 months of index procedure
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.	within 24 months of index procedure
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.	within 30 days of index procedure
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.	within 6 months of index procedure
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.	within 12 months of index procedure
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.	within 24 months of index procedure
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.	within 30 days of index procedure
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.	within 6 months of index procedure
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.	within 12 months of index procedure
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.	within 24 months of index procedure
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.	within 30 days of index procedure
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.	within 6 months of index procedure
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.	within 12 months of index procedure
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.	within 24 months of index procedure