Disrupt CAD IV With the Shockwave Coronary IVL System

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Myocardial Infarction
• Interventions: Device: Lithotripsy

• Registration Number: NCT04151628
• Lead Sponsor: Shockwave Medical, Inc.

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.

Study Timeline

• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-05
• Study Start: 2019-11-06
• Primary Completion: 2020-05-08
• Results First Submitted: 2021-03-12
• Results First Submitted QC: 2021-06-03
• Results First Posted: 2021-06-25
• Study Completion: 2022-03-25
• Status Verified: 2022-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronary Lithotripsy System	Lithotripsy	All subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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 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.
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.
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.
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.
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 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.
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.
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.
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.
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.

Trial Locations

Locations (8)

Sapporo Higashi Tokushukai Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Johas Kanto Rosai Hospital; 🇯🇵 Kawasaki, Kanagawa-Ken, Japan

Tenjinkai Shin-Koga Hospital; 🇯🇵 Kurume, Fukuoka-Ken, Japan

Higashi-Takarazuka Satoh Hospital; 🇯🇵 Takarazuka, Hyogo-Ken, Japan

Sakurakai Takahashi Hospital; 🇯🇵 Kobe, Hyogo-Ken, Japan

Shonan-Kamakura General Hospital; 🇯🇵 Kamakura, Kanagawa, Japan

Kyoto-Katsura Hospital; 🇯🇵 Kyoto-shi, Kyoto-Fu, Japan

Miyazaki Medical Association Hospital; 🇯🇵 Miyazaki, Miyazaki-Ken, Japan