| Primary | Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR). | This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
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| Primary | Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR). | This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
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| Primary | Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR). | This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
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| Secondary | Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap) | Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of <50%. | Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects | Posted | | Number | | Percentage of Lesions | | From start of index procedure to end of index procedure | Lesions | Lesions | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects |
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| Secondary | Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions) | Achievement of a final in-stent diameter stenosis of <50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days. | Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects. | Posted | | Number | | Percentage of Participants | | From the start of index procedure to end of index procedure | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects |
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| Secondary | In-Stent Late Loss | In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up. | Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent). | Posted | | Mean | Standard Deviation | Millimeters | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent |
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| Secondary | In-segment Late Loss (LL) | In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up. | Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent). | Posted | | Mean | Standard Deviation | Millimeters | | 240 Days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent |
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| Secondary | Proximal Late Loss | Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement). | Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent). | Posted | | Mean | Standard Deviation | Millimeter | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent |
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| Secondary | Distal Late Loss | Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement). | Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent). | Posted | | Mean | Standard Deviation | Millimeter | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent |
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| Secondary | In-stent % Diameter Stenosis | Value calculated as 100*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter. | Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent). | Posted | | Mean | Standard Deviation | Percentage | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent |
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| Secondary | In-segment % Diameter Stenosis | Value calculated as 100*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter. | Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent). | Posted | | Mean | Standard Deviation | Percentage | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent |
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| Secondary | Proximal % Diameter Stenosis | Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement. | Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent). | Posted | | Mean | Standard Deviation | Percentage | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent |
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| Secondary | Distal % Diameter Stenosis | Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement. | Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent). | Posted | | Mean | Standard Deviation | Percentage | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent |
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| Secondary | In-stent Angiographic Binary Restenosis (ABR) Rate | Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up. | Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent |
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| Secondary | In-segment Angiographic Binary Restenosis (ABR) Rate | Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up. | Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent |
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| Secondary | Proximal Angiographic Binary Restenosis (ABR) Rate | Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up. | Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent |
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| Secondary | Distal Angiographic Binary Restenosis (ABR) Rate | Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up. | Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent |
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| Secondary | All Death (Cardiac, Vascular, Non-cardiovascular) | All death, including death from cardiac, vascular, and non-cardiovascular causes. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
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| Secondary | All Death (Cardiac, Vascular, Non-cardiovascular) | All death, including death from cardiac, vascular, and non-cardiovascular causes. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
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| Secondary | All Death (Cardiac, Vascular, Non-cardiovascular) | All death, including death from cardiac, vascular, and non-cardiovascular causes. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
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| Secondary | All Death (Cardiac, Vascular, Non-cardiovascular) | All death, including death from cardiac, vascular, and non-cardiovascular causes. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
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| Secondary | All Death (Cardiac, Vascular, Non-cardiovascular) | All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
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| Secondary | Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) | Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
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| Secondary | Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) | Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
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| Secondary | Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) | Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) | Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
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| Secondary | Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) | Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
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| Secondary | Stent Thrombosis (ARC Defined) | ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | 0 to 1 day (Acute) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (ARC Defined) | ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | greater than 1 day to 30 days (Subacute) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (ARC Defined) | Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | 31 days - 393 days (Late) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (ARC Defined) | Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | >1 year (Very late) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (ARC Defined) | Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | 394 - 758 days (Very Late) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (ARC Defined) | Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | 394 - 1123 days (Very Late) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (ARC Defined) | Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | Overall (0 - 393 days) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (ARC Defined) | Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | Overall (0 - 758 days) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (ARC Defined) | Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | Overall (0 - 1123 days) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (Protocol Defined) | Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | 0 to 1 day (Acute) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (Protocol Defined) | Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | > 1 day to 30 days (Subacute) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (Protocol Defined) | Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | 31 days to 393 days (Late) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (Protocol Defined) | Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | 31 - 758 days (Late) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (Protocol Defined) | Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | Percentage of Participants | | 31 - 1123 days (Late) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (Protocol Defined) | Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | percentage of participants | | Overall (0 - 393 days) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (Protocol Defined) | Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | percentage of participants | | Overall (0 - 758 days) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Stent Thrombosis (Protocol Defined) | Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | | percentage of participants | | Overall (0 - 1123 days) | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All Death/ All MI/All Coronary Revascularization | This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All Death/ All MI/All Coronary Revascularization | This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All Death/ All MI/All Coronary Revascularization | This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All Death/ All MI/All Coronary Revascularization | This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All Death/ All MI/All Coronary Revascularization | This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Cardiac Death/ All MI /CI-TLR | This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Cardiac Death/ All MI /CI-TLR | This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Cardiac Death/ All MI /CI-TLR | This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Cardiac Death/ All MI /CI-TLR | This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Cardiac Death/ All MI /CI-TLR | This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Cardiac Death/MI | This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Cardiac Death/MI | This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Cardiac Death/MI | This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Cardiac Death/MI | This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Cardiac Death/MI | This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All Coronary Revascularization (TVR and Non-TVR) | Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All Coronary Revascularization (TVR and Non-TVR) | Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All Coronary Revascularization (TVR and Non-TVR) | Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All Coronary Revascularization (TVR and Non-TVR) | Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All Coronary Revascularization (TVR and Non-TVR) | Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel (per protocol). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All TVR (CI and Non-CI) | Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All TVR (CI and Non-CI) | Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All TVR (CI and Non-CI) | Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All TVR (CI and Non-CI) | Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All TVR (CI and Non-CI) | Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure (per protocol). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All TLR (CI and Non-CI) | Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All TLR (CI and Non-CI) | Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All TLR (CI and Non-CI) | Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All TLR (CI and Non-CI) | Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | All TLR (CI and Non-CI) | Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated (per protocol). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Clinically Indicated Target Vessel Revascularization (TVR) | Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Clinically Indicated Target Vessel Revascularization | Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Clinically Indicated Target Vessel Revascularization | Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Clinically Indicated Target Vessel Revascularization | Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Clinically Indicated Target Vessel Revascularization | Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Clinically Indicated Target Lesion Revascularization (CI-TLR) | Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Clinically Indicated Target Lesion Revascularization (CI-TLR) | Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Clinically Indicated Target Lesion Revascularization (CI-TLR) | Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Clinically Indicated Target Lesion Revascularization (CI-TLR) | Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms. | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Clinically Indicated Target Lesion Revascularization (CI-TLR) | Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) | Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) | Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) | Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) | Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) | Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Target Vessel MI - Q-wave and Non Q-wave (Per ARC) | ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Target Vessel MI - Q-wave and Non Q-wave (Per ARC) | ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Target Vessel MI - Q-wave and Non Q-wave (Per ARC) | ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Target Vessel MI - Q-wave and Non Q-wave (Per ARC) | ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Target Vessel MI - Q-wave and Non Q-wave (Per ARC) | ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) | ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) | ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 240 days | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) | ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) | ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |
| Secondary | Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) | ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351). | The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | 2.25mm XIENCE V® | Patients receiving the 2.25 mm XIENCE V® stent |
| |