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The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absorb GT1 BVS | Other | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABSORB GT1 BVS | Device | Patients receiving Absorb GT1 BVS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation. | Day 0 |
| Number of Participants With Sub Acute Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation. | >1 to 30 days |
| Number of Participants With Late Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masato Nakamura, MD | Toho University Ohashi Medical Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya Daini Red Cross Hospital | Nagoya | Aichi-ken | 466-8650 | Japan | ||
| Shin Tokyo Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38479861 | Derived | Nakamura M, Suzuki N, Fujii K, Furuya J, Kawasaki T, Kimura T, Sakamoto T, Tanabe K, Kusano H, Stockelman KA, Kozuma K. The Absorb GT1 Bioresorbable Vascular Scaffold System - 5-Year Post-Market Surveillance Study in Japan. Circ J. 2024 May 24;88(6):863-872. doi: 10.1253/circj.CJ-23-0877. Epub 2024 Mar 13. |
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This surveillance planned to consecutively enroll two thousand (2,000) patients. However, in September 2017, Abbott Vascular decided to stop selling the Absorb GT1 system globally, as result of low commercial sales uptake compared to the prediction. Surveillance sites could continue to use the device and register patients until December 15, 2017. As a result, 135 patients were enrolled (treatment with Absorb GT1 attempted, i.e., ITT) by December 11, 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Absorb GT1 BVS | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Absorb GT1 BVS | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Acute Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation. | Full Analysis Set (all participants with Absorb GT1) | Posted | Number | participants | Day 0 |
|
5 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Absorb GT1 BVS | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hajime Kusano | Abbott medical device | +1 408-845-1626 | hajime.kusano@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2016 | Mar 28, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2017 | Mar 28, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D000787 | Angina Pectoris |
| D003324 | Coronary Artery Disease |
| D054059 | Coronary Occlusion |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
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| 31 to 90 days |
| Number of Participants With Late Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation. | 31 to 365 days |
| Number of Participants With Very Late Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation. | 366 to 730 days |
| Number of Participants With Overall Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation | 0 to 90 days |
| Number of Participants With Cumulative Scaffold Thrombosis | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | 0 to 90 days |
| Number of Participants With Cumulative Scaffold Thrombosis | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | 0 to 730 days |
| Number of Participants With Exclusion of Very Small Vessels | For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD < 2.5 mm from registration by the last half of Phase 1. | During index procedure, "54.8 ± 27.6 min" |
| Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging | IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab. | During index procedure, "54.8 ± 27.6 min" |
| Number of Participants With Composite of Device Deficiencies | Device deficiencies: Number of participants with at least one of the following Device deficiencies
| During index procedure, "54.8 ± 27.6 min" |
| Number of Participants With Late Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation. | 731 - 1095 days |
| Number of Participants With Cumulative Scaffold Thrombosis | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation | 0 - 1095 days |
| Number of Participants With Very Late Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation | 1096 - 1460 days |
| Number of Participants With Cumulative Scaffold Thrombosis | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation | 0 - 1460 days |
| Number of Participants With Cumulative Scaffold Thrombosis | Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation. | 0 - 1825 days |
| 0 to 30 days |
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 0 to 90 days |
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 0 to 1 year |
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 0 to 2 years |
| Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | 0 to 30 days |
| Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | 0 to 90 days |
| Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | 0 to 1 year |
| Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | 0 to 2 years |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 0 to 30 days |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 0 to 90 days |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 0 to 1 year |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 0 to 2 years |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 0 to 30 days |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 0 to 90 days |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 0 to 1 year |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 0 to 2 years |
| Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | 0 to 30 days |
| Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | 0 to 90 days |
| Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | 0 to 1 year |
| Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | 0 to 2 years |
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 0 to 30 days |
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 0 to 90 days |
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 0 to 1 year |
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 0 to 2 years |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 0 to 30 days |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 0 to 90 days |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR) | 0 to 1 Year |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR) | 0 to 2 years |
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | 0 to 30 days |
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | 0 to 90 days |
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | 0 to 1 year |
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | 0 to 2 years |
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 0 to 30 days |
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 0 to 90 days |
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 0 to 1 year |
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 0 to 2 years |
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | 0 to 30 days |
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | 0 to 90 days |
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | 0 to 1 year |
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | 0 to 2 years |
| Angiographic Endpoints (Core Lab Analysis): Lesion Morphology | Pre-procedure |
| Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow | TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely | Pre-procedure |
| Angiographic Endpoints (Core Lab Analysis): Lesion Length | Lesion Length (can be measured after successful post-dilatation) | Pre-procedure |
| Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD) | Proximal RVD (can be measured after successful post-dilatation) | Pre-procedure |
| Angiographic Endpoints (Core Lab Analysis): Distal RVD | Distal RVD (can be measured after successful post-dilatation) | Pre-procedure |
| Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD) | Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen | Pre-procedure |
| Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS) | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). | Pre-procedure |
| Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow | TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
| Angiographic Endpoints (Core Lab Analysis): MLD (In-segment) | Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold. | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
| Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment ) | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold. | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
| Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment ) | The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD). | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
| IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) | Pre-procedure (or after pre-dilatation) |
| IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
| IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
| IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition | Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
| IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture | Strut fracture will be measured as either number or percentage post-procedure | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 3 years |
| Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | 3 years |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 3 years |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 3 years |
| Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | 3 years |
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 3 years |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 3 years |
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | 3 years |
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 3 years |
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | 3 years |
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 4 years |
| Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | 4 years |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 4 years |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 4 years |
| Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | 4 years |
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 4 years |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 4 years |
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | 4 years |
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 4 years |
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | 4 years |
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 5 years |
| Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | 5 years |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 5 years |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 5 years |
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. | 5 years |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 5 years |
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR). | 5 years |
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 5 years |
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | 5 years |
| Matsudo |
| Chiba |
| 270-2232 |
| Japan |
| Shin Koga Hospital | Kurume | Fukuoka | 830-8577 | Japan |
| Hanaoka Seishu Memorial Cardiovascular Clinic | Sapporo | Hokkaido | 062-0003 | Japan |
| Kobe University | Kobe | Hyōgo | 650-0017 | Japan |
| Iwate Medical University | Morioka | Iwate | 020-8505 | Japan |
| Shonan Kamakura General Hospital | Kamakura | Kanagawa | 247-8533 | Japan |
| Kurashiki Central Hospital | Kurashiki | Okayama-ken | 710-8602 | Japan |
| Saitama Sekishinkai Hospital | Sayama | Saitama | 350-1323 | Japan |
| Mitsui Memorial Museum | Chiyoda City | Tokyo | 101-8643 | Japan |
| Toho University Ohashi Medical Center | Meguro City | Tokyo | 153-8515 | Japan |
| Teikyo University | tabashi City | Tokyo | 173-8606 | Japan |
| Saiseikai Kumamoto Hospital | Kumamoto | 861-4193 | Japan |
| Miyazaki Medical Association Hospital | Miyazaki | 880-0834 | Japan |
| Sakurabashi Watanabe Hospital | Osaka | 530-0001 | Japan |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Diabetes Mellitus | Count of Participants | Participants |
|
| Dyslipidemia | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
|
| Renal Failure | Count of Participants | Participants |
|
| Prior Coronary Intervention | Count of Participants | Participants |
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| Previous Myocardial Infarction (MI) | Count of Participants | Participants |
|
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
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| Primary | Number of Participants With Sub Acute Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation. | Full Analysis Set (all participants with Absorb GT1) | Posted | Number | participants | >1 to 30 days |
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| Primary | Number of Participants With Late Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation. | Full Analysis Set (all participants with Absorb GT1) | Posted | Number | participants | 31 to 90 days |
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| Primary | Number of Participants With Late Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation. | Full Analysis Set (all participants with Absorb GT1) | Posted | Number | participants | 31 to 365 days |
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| Primary | Number of Participants With Very Late Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation. | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 366 to 730 days |
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| Primary | Number of Participants With Overall Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 90 days |
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| Primary | Number of Participants With Cumulative Scaffold Thrombosis | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | Full Analysis Set (all participants with Absorb GT1) | Posted | Number | participants | 0 to 90 days |
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| Primary | Number of Participants With Cumulative Scaffold Thrombosis | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 0 to 730 days |
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| Primary | Number of Participants With Exclusion of Very Small Vessels | For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD < 2.5 mm from registration by the last half of Phase 1. | Full Analysis Set (phase 1 participants with Absorb GT1) | Posted | Number | participants | During index procedure, "54.8 ± 27.6 min" | Lesions | Lesions |
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| Primary | Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging | IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | During index procedure, "54.8 ± 27.6 min" |
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| Primary | Number of Participants With Composite of Device Deficiencies | Device deficiencies: Number of participants with at least one of the following Device deficiencies
| Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | During index procedure, "54.8 ± 27.6 min" |
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| Primary | Number of Participants With Late Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 731 - 1095 days |
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| Primary | Number of Participants With Cumulative Scaffold Thrombosis | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 - 1095 days |
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| Primary | Number of Participants With Very Late Scaffold Thrombosis (ST) | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 1096 - 1460 days |
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| Primary | Number of Participants With Cumulative Scaffold Thrombosis | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 - 1460 days |
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| Primary | Number of Participants With Cumulative Scaffold Thrombosis | Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation. | Full Analysis Set (all participants with Absorb GT1) | Posted | Number | participants | 0 - 1825 days |
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| Secondary | Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 30 days |
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| Secondary | Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 90 days |
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| Secondary | Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 1 year |
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| Secondary | Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 0 to 2 years |
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| Secondary | Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 30 days |
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| Secondary | Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 90 days |
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| Secondary | Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 1 year |
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| Secondary | Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 0 to 2 years |
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| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 30 days |
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| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 90 days |
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| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 1 year |
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| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 0 to 2 years |
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|
|
| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 30 days |
|
|
|
| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 90 days |
|
|
|
| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 1 year |
|
|
|
| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 0 to 2 years |
|
|
|
| Secondary | Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 30 days |
|
|
|
| Secondary | Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 90 days |
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|
|
| Secondary | Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 1 year |
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|
|
| Secondary | Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 0 to 2 years |
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|
|
| Secondary | Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 30 days |
|
|
|
| Secondary | Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 90 days |
|
|
|
| Secondary | Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 1 year |
|
|
|
| Secondary | Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 0 to 2 years |
|
|
|
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 30 days |
|
|
|
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 90 days |
|
|
|
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 1 Year |
|
|
|
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR) | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 0 to 2 years |
|
|
|
| Secondary | Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 30 days |
|
|
|
| Secondary | Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 90 days |
|
|
|
| Secondary | Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 1 year |
|
|
|
| Secondary | Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 0 to 2 years |
|
|
|
| Secondary | Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 30 days |
|
|
|
| Secondary | Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 90 days |
|
|
|
| Secondary | Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 1 year |
|
|
|
| Secondary | Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 0 to 2 years |
|
|
|
| Secondary | Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 30 days |
|
|
|
| Secondary | Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 90 days |
|
|
|
| Secondary | Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 0 to 1 year |
|
|
|
| Secondary | Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 0 to 2 years |
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|
| Secondary | Angiographic Endpoints (Core Lab Analysis): Lesion Morphology | Full Analysis Set (all participants with Absorb GT1) | Posted | Number | percentage of lesions | Pre-procedure | Lesions | Lesions |
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| Secondary | Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow | TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely | Full Analysis Set (all participants with Absorb GT1) | Posted | Number | percentage of TIMI flow | Pre-procedure | Lesion | Lesion |
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| Secondary | Angiographic Endpoints (Core Lab Analysis): Lesion Length | Lesion Length (can be measured after successful post-dilatation) | Full Analysis Set (all participants with Absorb GT1) | Posted | Mean | Standard Deviation | mm | Pre-procedure | Lesions | Lesions |
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| Secondary | Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD) | Proximal RVD (can be measured after successful post-dilatation) | Full Analysis Set (all participants with Absorb GT1) | Posted | Mean | Standard Deviation | mm | Pre-procedure | Lesions | Lesions |
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| Secondary | Angiographic Endpoints (Core Lab Analysis): Distal RVD | Distal RVD (can be measured after successful post-dilatation) | Full Analysis Set (all participants with Absorb GT1) | Posted | Mean | Standard Deviation | mm | Pre-procedure | Lesions | Lesions |
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| Secondary | Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD) | Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen | Full Analysis Set (all participants with Absorb GT1) | Posted | Mean | Standard Deviation | mm | Pre-procedure | Lesions | Lesions |
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| Secondary | Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS) | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). | Full Analysis Set (all participants with Absorb GT1) | Posted | Mean | Standard Deviation | percentage of diameter | Pre-procedure | Lesions | Lesions |
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|
|
| Secondary | Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow | TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely | Full Analysis Set (all participants with Absorb GT1) | Posted | Number | percentage of TIMI flow | Post-procedure (average procedure time of "54.8 ± 27.6 min") | Lesion | Lesion |
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|
|
| Secondary | Angiographic Endpoints (Core Lab Analysis): MLD (In-segment) | Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold. | Full Analysis Set (all participants with Absorb GT1) | Posted | Mean | Standard Deviation | mm | Post-procedure (average procedure time of "54.8 ± 27.6 min") | Lesions | Lesions |
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|
|
| Secondary | Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment ) | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold. | Full Analysis Set (all participants with Absorb GT1) | Posted | Mean | Standard Deviation | percentage of diameter | Post-procedure (average procedure time of "54.8 ± 27.6 min") | Lesions | Lesions |
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| Secondary | Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment ) | The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD). | Full Analysis Set (all participants with Absorb GT1) | Posted | Mean | Standard Deviation | mm | Post-procedure (average procedure time of "54.8 ± 27.6 min") | Lesions | Lesions |
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| Secondary | IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Mean | Standard Deviation | mm^2 | Pre-procedure (or after pre-dilatation) | Lesions | Lesions |
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|
| Secondary | IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) | Full Analysis Set (all participants with Absorb GT1) | Posted | Mean | Standard Deviation | mm^2 | Post-procedure (average procedure time of "54.8 ± 27.6 min") | Lesions | Lesions |
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|
|
| Secondary | IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area | Full Analysis Set (all participants with Absorb GT1). | Posted | Mean | Standard Deviation | mm^2 | Post-procedure (average procedure time of "54.8 ± 27.6 min") | Lesions | Lesions |
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| Secondary | IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition | Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure | Full Analysis Set (all participants with Absorb GT1) | Posted | Mean | Standard Deviation | Percentage of lesions | Post-procedure (average procedure time of "54.8 ± 27.6 min") | Lesions | Lesions |
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|
|
| Secondary | IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture | Strut fracture will be measured as either number or percentage post-procedure | Full Analysis Set (all participants with Absorb GT1) | Posted | Number | Lesions | Post-procedure (average procedure time of "54.8 ± 27.6 min") | Lesions | Lesions |
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|
|
| Secondary | Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 3 years |
|
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|
| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Participants With All Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR). | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Participants With Cardiac Death/Myocardial Infarction (MI) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. | Full Analysis Set (all participants with Absorb GT1) | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 4 |
| 135 |
| 43 |
| 135 |
| 8 |
| 135 |
| Angina, unstable | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Hepatic Enzyme Increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Oesophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebral artery occlusion | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Subclavian artery stenosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Phimosis | Congenital, familial and genetic disorders | MedDRA (11.0) | Systematic Assessment |
|
| Thrombosis in Device | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebral artery stenosis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dermal Eruption | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Coronary Revascularization | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
Not provided
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| > 3.5 mm |
|
| Title | Measurements |
|---|---|
|
| Re-crossing difficulty |
|
| Post-dilatation balloon+OCT/IVUS |
|
| IFU not included |
|
| Major Strut Malapposition |
|
| Strut Fracture within 6 months |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Total Occlusion |
|
| Title | Measurements |
|---|
|
| 3 |
|
| Title | Measurements |
|---|
|
| 3 |
|