XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE Xpedition SV Japan PMS)

Coronary Artery Disease Clinical Trial

Official title:

XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513732
• Other study ID #: 14-306
• Status: Completed
• Start date: July 2014
• Est. completion date: September 2020

Study information

• Verified date: April 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.

Description:

Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE Xpedition Everolimus-Eluting 2.25mm Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year. The XIENCE Xpedition 2.25 mm stent is composed of the stent identical to the stent of the XIENCE PRIME SV Stent.Therefore, the data collected from the PMS will be pooled with data collected from the ongoing XIENCE PRIME SV PMS for analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

1. Inclusion criteria

1. Patient informed consent is required for registration of this PMS. In cases where patient informed consent (or providing some type of information) is required for PMS per the participating site policy, the Sponsor will cooperate as needed.

2. Patients who are treated by XIENCE Xpedition 2.25mm stent will be registered.

• The observations will be compiled on a per-patient basis even if multiple XIENCE Xpedition 2.25mm stents are implanted during the index procedure.
• A patient whose side-branch is treated by XIENCE Xpedition 2.25mm stent can be registered. In such a case, main vessel should be treated by XIENCE Xpedition.
• The observations will not be compiled on a per-patient basis if a patient is treated by XIENCE Xpedition 2.25mm stent overlapped with other stents for bail-out purpose.
• Additional revascularization procedures as a part of adverse event treatment and planned staged procedures will not be considered as another registration, or adverse events.
• A patient who is treated, but failed to be implanted by XIENCE Xpedition 2.25mm stent and finally treated by other devices only (No XIENCE Xpedition 2.25mm stent are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the Xpedition stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE Xpedition 2.25mm stent is not required.

2. Exclusion criteria

1. If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.

2. Patients who are attending or will attend other PMS with invasive medical procedure will not be registered.

3. A patient may have another lesion(s) that may be treated by larger diameter (= 2.5mm) stent(s). In such a case, treatment by XIENCE Xpedition is preferable. Lesion(s) treated by other than XIENCE Xpedition 2.25mm stent is not considered as the target lesion.

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• XIENCE Xpedition 2.25 mm stent
Patients receiving XIENCE Xpedition 2.25 mm stent

Locations

Country	Name	City	State
Japan	Hyogo Prefectural Amagasaki Hospital	Hyogo
Japan	Ishikawa Prefectural Central Hospital	Ishikawa
Japan	Miyazaki Medical Association Hospital	Miyazaki
Japan	Osaka Police Hospital	Osaka
Japan	Hanaoka Seishu Memorial Cardiovascular Clinic	Sapporo
Japan	JCHO Hokkaido Hospital	Sapporo
Japan	Tokushima Red Cross Hospital	Tokushima
Japan	Mitsui Memorial Hospital	Tokyo
Japan	Teikyo University Hospital	Tokyo
Japan	Toranomon Hospital	Tokyo
Japan	Showa University Fujigaoka Hospital	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Stent Thrombosis: Late	Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.; Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation	30 days to 1 year post stent implantation-Day 212
Secondary	Percent Diameter Stenosis (%DS)	In-segment, In-stent, Proximal and Distal. The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).	Pre-procedure
Secondary	Percent Diameter Stenosis (%DS)	In-segment, In-stent, Proximal and Distal. The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).	Immediately after the procedure
Secondary	Percent Diameter Stenosis (%DS)	In-segment, In-stent, Proximal and Distal. The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).	During follow-up, at 8 months post procedure
Secondary	Number of Participants Using Antiplatelet Therapy	Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.	At baseline before procedure
Secondary	Number of Participants Using Antiplatelet Therapy	Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.	Date of discharge from procedure day
Secondary	Number of Participants Using Antiplatelet Therapy	Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.	8 months observation day from the procedure day
Secondary	Number of Participants Using Antiplatelet Therapy	Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.	1 year observation day from the procedure day
Secondary	Number of Participants Using Antiplatelet Therapy	Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.	2 years observation day from the procedure day
Secondary	Number of Participants Using Antiplatelet Therapy	Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.	3 years observation day from the procedure day
Secondary	Number of Participants Using Antiplatelet Therapy	Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.	4 years observation day from the procedure day
Secondary	Number of Participants Using Antiplatelet Therapy	Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.	5 years observation day from the procedure day
Secondary	Number of Participants With Death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	During hospitalization
Secondary	Number of Participants With Death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	0 to 8 months
Secondary	Number of Participants With Death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	0 to 1 year
Secondary	Number of Participants With Death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	0 to 2 years
Secondary	Number of Participants With Death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	0 to 3 years
Secondary	Number of Participants With Death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	0 to 4 years
Secondary	Number of Participants With Death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	0 to 5 years
Secondary	Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	During hospitalization
Secondary	Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	0 to 8 months
Secondary	Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	0 to 1 year
Secondary	Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	0 to 2 years
Secondary	Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	0 to 3 years
Secondary	Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	0 to 4 years
Secondary	Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	0 to 5 years
Secondary	Number of Participants With Myocardial Infarction	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	During hospitalization
Secondary	Number of Participants With Myocardial Infarction	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 8 months
Secondary	Number of Participants With Myocardial Infarction	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 1 year
Secondary	Number of Participants With Myocardial Infarction	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 2 years
Secondary	Number of Participants With Myocardial Infarction	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 3 years
Secondary	Number of Participants With Myocardial Infarction	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 4 years
Secondary	Number of Participants With Myocardial Infarction	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 5 years
Secondary	Number of Participants With Cardiac Death	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)	During hospitalization
Secondary	Number of Participants With Cardiac Death	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)	0 to 8 months
Secondary	Number of Participants With Cardiac Death	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)	0 to 1 year
Secondary	Number of Participants With Cardiac Death	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)	0 to 2 years
Secondary	Number of Participants With Cardiac Death	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)	0 to 3 Years
Secondary	Number of Participants With Cardiac Death	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)	0 to 4 years
Secondary	Number of Participants With Cardiac Death	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)	0 to 5 years
Secondary	Number of Participants With MI Related to Target Vessel	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	During hospitalization
Secondary	Number of Participants With MI Related to Target Vessel	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 8 months
Secondary	Number of Participants With MI Related to Target Vessel	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 1 year
Secondary	Number of Participants With MI Related to Target Vessel	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 2 years
Secondary	Number of Participants With MI Related to Target Vessel	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 3 years
Secondary	Number of Participants With MI Related to Target Vessel	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 4 years
Secondary	Number of Participants With MI Related to Target Vessel	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 5 years
Secondary	Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	During hospitalization
Secondary	Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	0 to 8 months
Secondary	Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	0 to 1 year
Secondary	Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	0 to 2 years
Secondary	Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	0 to 3 years
Secondary	Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	0 to 4 years
Secondary	Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	0 to 5 years
Secondary	Number of Participants With All Revascularization	All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.	During hospitalization
Secondary	Number of Participants With All Revascularization	All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.	0 to 8 months
Secondary	Number of Participants With All Revascularization	All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.	0 to 1 year
Secondary	Number of Participants With All Revascularization	All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.	0 to 2 years
Secondary	Number of Participants With All Revascularization	All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.	0 to 3 years
Secondary	Number of Participants With All Revascularization	All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.	0 to 4 years
Secondary	Number of Participants With All Revascularization	All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.	0 to 5 years
Secondary	Number of Participants With Target Vessel Failure (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	During hospitalization
Secondary	Number of Participants With Target Vessel Failure (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	0 to 8 months
Secondary	Number of Participants With Target Vessel Failure (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	0 to 1 year
Secondary	Number of Participants With Target Vessel Failure (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	0 to 2 years
Secondary	Number of Participants With Target Vessel Failure (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	0 to 3 years
Secondary	Number of Participants With Target Vessel Failure (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	0 to 4 years
Secondary	Number of Participants With Target Vessel Failure (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	0 to 5 years
Secondary	Number of Participants With Target Vessel Revascularization (Non-TLR)	Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.	During hospitalization
Secondary	Number of Participants With Target Vessel Revascularization (Non-TLR)	Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.	0 to 8 months
Secondary	Number of Participants With Target Vessel Revascularization (Non-TLR)	Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.	0 to 1 year
Secondary	Number of Participants With Target Vessel Revascularization (Non-TLR)	Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.	0 to 2 years
Secondary	Number of Participants With Target Vessel Revascularization (Non-TLR)	Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.	0 to 3 years
Secondary	Number of Participants With Target Vessel Revascularization (Non-TLR)	Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.	0 to 4 years
Secondary	Number of Participants With Target Vessel Revascularization (Non-TLR)	Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.	0 to 5 years
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).	During hospitalization
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).	0 to 8 months
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).	0 to 1 year
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).	0 to 2 years
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).	0 to 3 years
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).	0 to 4 years
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).	0 to 5 years
Secondary	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	During hospitalization
Secondary	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	0 to 8 months
Secondary	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	0 to 1 year
Secondary	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	0 to 2 years
Secondary	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	0 to 3 years
Secondary	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	0 to 4 years
Secondary	Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	0 to 5 years
Secondary	Number of Participants With Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	During hospitalization
Secondary	Number of Participants With Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 8 months
Secondary	Number of Participants With Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 1 year
Secondary	Number of Participants With Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 2 years
Secondary	Number of Participants With Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 3 years
Secondary	Number of Participants With Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 4 years
Secondary	Number of Participants With Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 5 years
Secondary	Number of Participants With Cardiac Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	During hospitalization
Secondary	Number of Participants With Cardiac Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 8 months
Secondary	Number of Participants With Cardiac Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 1 year
Secondary	Number of Participants With Cardiac Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 2 years
Secondary	Number of Participants With Cardiac Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 3 years
Secondary	Number of Participants With Cardiac Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 4 years
Secondary	Number of Participants With Cardiac Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 5 years
Secondary	Number of Participants With Cardiac Death or Target-Vessel MI	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).	During hospitalization
Secondary	Number of Participants With Cardiac Death or Target-Vessel MI	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).	0 to 8 months
Secondary	Number of Participants With Cardiac Death or Target-Vessel MI	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).	0 to 1 year
Secondary	Number of Participants With Cardiac Death or Target-Vessel MI	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).	0 to 2 years
Secondary	Number of Participants With Cardiac Death or Target-Vessel MI	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).	0 to 3 years
Secondary	Number of Participants With Cardiac Death or Target-Vessel MI	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).	0 to 4 years
Secondary	Number of Participants With Cardiac Death or Target-Vessel MI	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).	0 to 5 years
Secondary	Number of Participants With Target Lesion Failure (TLF)	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).	During hospitalization
Secondary	Number of Participants With Target Lesion Failure (TLF)	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 8 months
Secondary	Number of Participants With Target Lesion Failure (TLF)	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 1 year
Secondary	Number of Participants With Target Lesion Failure (TLF)	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 2 years
Secondary	Number of Participants With Target Lesion Failure (TLF)	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 3 years
Secondary	Number of Participants With Target Lesion Failure (TLF)	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 4 years
Secondary	Number of Participants With Target Lesion Failure (TLF)	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 5 years
Secondary	Mean Acute Gain: In-stent, In-segment	The difference between post- and pre-procedural MLD.	At 8 months, post index procedure
Secondary	Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal	Late loss is calculated as MLD post procedure - MLD at follow-up.	At 8 months, post index procedure
Secondary	Mean Net Gain: In-stent, In-segment	Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).	At 8 months, post index procedure
Secondary	Mean Lesion Length	The lesion length will be measured by QCA.	Pre-procedure
Secondary	Minimum Blood Vessel Diameter	Minimum blood vessel diameter measured by QCA	Pre-procedure
Secondary	Minimum Blood Vessel Diameter	Minimum blood vessel diameter measured by QCA	Immediately after the procedure
Secondary	Minimum Blood Vessel Diameter	Minimum blood vessel diameter measured by QCA	During follow-up, at 8 months post procedure
Secondary	Mean Reference Vessel Diameter (RVD)	Reference vessel diameter measured by QCA	Pre-procedure
Secondary	Mean Reference Vessel Diameter (RVD)	Reference vessel diameter measured by QCA	Immediately after the procedure
Secondary	Mean Reference Vessel Diameter (RVD)	Reference vessel diameter measured by QCA	During follow-up, at 8 months post procedure