| Primary | Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | Acute Success: Clinical Device Success (Lesion Level Analysis) | Device success was defined as the achievement of a final in-scaffold residual diameter stenosis of <50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success. | | Posted | | Number | 95% Confidence Interval | percentage of lesions | | < or = 1 day | Target Lesions | Participants | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Acute Success: Clinical Procedure Success (Per Subject Analysis) | Procedure success was defined as the achievement of a final in-scaffold diameter stenosis of <50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | During the hospital stay with a maximum of 3 days post index procedure | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Acute Scaffold Thrombosis | | Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event. | Posted | | Number | | percentage of participants | | <1 day | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| | |
| Secondary | Subacute ScaffoldThrombosis | | Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event. | Posted | | Number | | percentage of participants | | 1 to 30 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| | |
| Secondary | Late Scaffold Thrombosis | | Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event. | Posted | | Number | | percentage of participants | | 31 to 365 Days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| | |
| Secondary | All Death, All MI, All Revascularization (DMR) | | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Major Adverse Cardiac Event (MACE) | MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Cardiac Death/All MI | | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Death/All MI | | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Death, All MI, All Revascularization (DMR) | | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Major Adverse Cardiac Event (MACE) | MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 - 37 Days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 37 Days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Cardiac Death/All MI | | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Death/All MI | | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Death, All MI, All Revascularization (DMR) | | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Major Adverse Cardiac Event (MACE) | MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 Days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 Days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Cardiac Death/All MI | | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Death/All MI | | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Death, All MI, All Revascularization (DMR) | | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Major Adverse Cardiac Event (MACE) | MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 Days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Cardiac Death/All MI | | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Death/All MI | | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Death (Cardiovascular, Non-Cardiovascular) | This is one of the Safety Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | This is one of the Safety Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Lesion Revascularization (TLR): All TLR | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Vessel Revascularization (TVR): All TVR | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Vessel Revascularization : Ischemic-driven (ID-TVR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Revascularization | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 7 days (In-hospital) | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Death (Cardiovascular, Non-Cardiovascular) | This is one of the Safety Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | This is one of the Safety Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Lesion Revascularization (TLR): All TLR | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Vessel Revascularization (TVR): All TVR | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Vessel Revascularization : Ischemic-driven (ID-TVR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Revascularization | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Death (Cardiovascular, Non-Cardiovascular) | This is one of the Safety Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | This is one of the Safety Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Lesion Revascularization (TLR): All TLR | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Vessel Revascularization (TVR): All TVR | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Vessel Revascularization : Ischemic-driven (ID-TVR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Revascularization | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 180 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Death (Cardiovascular, Non-Cardiovascular) | This is one of the Safety Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | This is one of the Safety Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Lesion Revascularization (TLR): All TLR | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Vessel Revascularization (TVR): All TVR | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | Target Vessel Revascularization : Ischemic-driven (ID-TVR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |
| Secondary | All Revascularization | This is one of the Efficacy Component (non-hierarchical) endpoints. | Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 0 to 407 days | | | | ID | Title | Description |
|---|
| OG000 | Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold |
| |