ABSORB Clinical Investigation, Cohort B

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels. Currently in development at Abbott Vascular. Not available for sale in the United States.

Official Title
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A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.

Conditions
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Coronary Disease, Coronary Artery Disease, Coronary Restenosis

Intervention / Treatment
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* Device: Bioabsorbable Everolimus Eluting Coronary Stent


Participation Criteria
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Eligibility Criteria
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General inclusion criteria Patient must be at least 18 years of age. Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia) Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional) Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure Angiographic Inclusion Criteria Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm Target lesion(s) must measure ≤ 14 mm in length by visual estimation Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1 If two target lesions meet the inclusion criteria they must be in different major epicardial vessels left anterior descending artery (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches If two target lesion(s) are being treated, each of these lesions must meet all angiographic inclusion/exclusion criteria Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥ 90 days prior to or if planned to be done 6 months after the index procedure Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure General Exclusion Criteria Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure The patient is currently experiencing clinical symptoms consistent with AMI Patient has current unstable arrhythmias Patient has a known left ventricular ejection fraction (LVEF) < 30% Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.) Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin) Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, poly (L-lactide), poly (DL-lactide) or contrast sensitivity that cannot be adequately pre-medicated Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell count of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis) Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis) Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months Patient has had a significant GI or urinary bleed within the past six months Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year) Patient is already participating in another clinical investigation that has not yet reached its primary endpoint Pregnant or nursing patients and those who plan pregnancy during the Clinical Investigation. (Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used during participation in this Clinical Investigation) Patient has received brachytherapy in any epicardial vessel (including side branches) Angiographic Exclusion Criteria Target lesion(s) meets any of the following criteria: Aorto-ostial location (within 3 mm) Left main location Located within 2 mm of the origin of the LAD or LCX Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion, by visual estimation) arterial or saphenous vein graft Lesion involving a bifurcation ≥ 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation Total occlusion (TIMI flow 0), prior to wire crossing Excessive tortuosity proximal to or within the lesion Extreme angulation (≥ 90%) proximal to or within the lesion Heavy calcification Restenotic from previous intervention The target vessel contains visible thrombus Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches) Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Absorb stent<br>Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) | Device: Bioabsorbable Everolimus Eluting Coronary Stent<br>* Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hierarchical Major Adverse Cardiac Event (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). | 30 days | 
| Hierarchical Major Adverse Cardiac Event (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). | 1 year | 
| In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days | In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up. | 180 days | 
| In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year | In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Device Success (Per Lesion) | Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met. | On day 0 (the day of procedure) | 
| Clinical Procedure Success (Per Patient) | Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. | On day 0 (the day of procedure) | 
| Hierarchical Major Adverse Cardiac Event (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). | 180 days | 
| Hierarchical Major Adverse Cardiac Event (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). | 270 days | 
| Hierarchical Major Adverse Cardiac Event (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). | 2 years | 
| Hierarchical Major Adverse Cardiac Event (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). | 3 years | 
| Hierarchical Major Adverse Cardiac Event (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). | 4 years | 
| Hierarchical Major Adverse Cardiac Event (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). | 5 years | 
| Hierarchical 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). | 30 days | 
| Hierarchical 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). | 180 days | 
| Hierarchical 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). | 270 days | 
| Hierarchical 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). | 1 year | 
| Hierarchical 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). | 2 years | 
| Hierarchical 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 | 
| Hierarchical 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 | 
| Hierarchical 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 | 
| Ischemia Driven Target Lesion Revascularization (ID-TLR) | ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 30 days | 
| Ischemia Driven Target Lesion Revascularization (ID-TLR) | ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 180 days | 
| Ischemia Driven Target Lesion Revascularization (ID-TLR) | ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 270 days | 
| Ischemia Driven Target Lesion Revascularization (ID-TLR) | ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 1 year | 
| Ischemia Driven Target Lesion Revascularization (ID-TLR) | ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 2 years | 
| Ischemia Driven Target Lesion Revascularization (ID-TLR) | ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 3 years | 
| Ischemia Driven Target Lesion Revascularization (ID-TLR) | ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 4 years | 
| Ischemia Driven Target Lesion Revascularization (ID-TLR) | ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 5 years | 
| Ischemia Driven Target Vessel Revascularization (ID-TVR) | ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 30 days | 
| Ischemia Driven Target Vessel Revascularization (ID-TVR) | ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 180 days | 
| Ischemia Driven Target Vessel Revascularization (ID-TVR) | ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 270 days | 
| Ischemia Driven Target Vessel Revascularization (ID-TVR) | ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 1 year | 
| Ischemia Driven Target Vessel Revascularization (ID-TVR) | ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 2 years | 
| Ischemia Driven Target Vessel Revascularization (ID-TVR) | ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 3 years | 
| Ischemia Driven Target Vessel Revascularization (ID-TVR) | ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 4 years | 
| Ischemia Driven Target Vessel Revascularization (ID-TVR) | ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. | 5 years | 
| Cardiac Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) | 30 days | 
| Cardiac Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) | 1 year | 
| Cardiac Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) | 2 years | 
| Cardiac Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) | 3 years | 
| Cardiac Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) | 4 years | 
| Cardiac Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) | 5 years | 
| Myocardial Infarction | Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 30 days | 
| Myocardial Infarction | Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 1 year | 
| Myocardial Infarction | Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 2 years | 
| Myocardial Infarction | Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 3 years | 
| Myocardial Infarction | Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 4 years | 
| Myocardial Infarction | Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 5 years | 
| Scaffold Thrombosis | Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis. | 30 days | 
| Scaffold Thrombosis | Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis. | 1 year | 
| Scaffold Thrombosis | Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis. | 2 years | 
| Scaffold Thrombosis | Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis. | 3 years | 
| Scaffold Thrombosis | Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis. | 4 years | 
| Scaffold Thrombosis | Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis. | 5 years | 
| In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years | In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up. | 2 years | 
| In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years | In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up. | 3 years | 
| In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years | In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up. | 5 years | 
| Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days | Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement). | 180 days | 
| Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year | Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement). | 1 year | 
| Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years | Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement). | 2 years | 
| Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years | Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement). | 3 years | 
| Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years | Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement). | 5 years | 
| Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days | Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement). | 180 days | 
| Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year | Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement). | 1 year | 
| Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years | Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement). | 2 years | 
| Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years | Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement). | 3 years | 
| Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years | Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement). | 5 years | 
| In-scaffold Angiographic Binary Restenosis (ABR) | Percent of patients with a followup percent diameter stenosis of >=50% per QCA. | 180 days | 
| In-scaffold Angiographic Binary Restenosis (ABR) | Percent of patients with a followup percent diameter stenosis of >=50% per QCA. | 1 year | 
| In-scaffold Angiographic Binary Restenosis (ABR) | Percent of patients with a followup percent diameter stenosis of >=50% per QCA. | 2 years | 
| In-scaffold Angiographic Binary Restenosis (ABR) | Percent of patients with a followup percent diameter stenosis of >=50% per QCA. | 3 years | 
| In-scaffold Angiographic Binary Restenosis (ABR) | Percent of patients with a followup percent diameter stenosis of >=50% per QCA. | 5 years | 
| Persisting Dissection | Dissection at follow-up that was present post-procedure. | 180 days | 
| Persisting Dissection | Dissection at follow-up that was present post-procedure. | 1 year | 
| Persisting Dissection | Dissection at follow-up that was present post-procedure. | 2 years | 
| Persisting Dissection | Dissection at follow-up that was present post-procedure. | 3 years | 
| Persisting Dissection | Dissection at follow-up that was present post-procedure. | 5 years | 
| In-scaffold Percent Diameter Stenosis (%DS) | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | 180 days | 
| In-scaffold Percent Diameter Stenosis (%DS) | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | 1 year | 
| In-scaffold Percent Diameter Stenosis (%DS) | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | 2 years | 
| In-scaffold Percent Diameter Stenosis (%DS) | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | 3 years | 
| In-scaffold Percent Diameter Stenosis (%DS) | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | 5 years | 
| Aneurysm | An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times. | 180 days | 
| Aneurysm | An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times. | 1 year | 
| Aneurysm | An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times. | 2 years | 
| Aneurysm | An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times. | 3 years | 
| Aneurysm | An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times. | 5 years | 
| Thrombus |  | 180 days | 
| Thrombus |  | 1 year | 
| Thrombus |  | 2 years | 
| Thrombus |  | 3 years | 
| Thrombus |  | 5 years | 
| Vasomotion Analysis: In-scaffold Mean Luminal Diameter | Vasomotion function was assessed in reaction to nitrate administration. | 5 years | 
| Volume Obstruction (VO) | Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS. | 180 days | 
| Volume Obstruction (VO) | Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS. | 1 year | 
| Volume Obstruction (VO) | Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS. | 2 year | 
| Volume Obstruction (VO) | Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS. | 3 year | 
| Persisting Incomplete Apposition | Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image. | 180 days | 
| Persisting Incomplete Apposition | Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image. | 1 year | 
| Persisting Incomplete Apposition | Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image. | 2 year | 
| Persisting Incomplete Apposition | Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image. | 3 year | 
| Late Incomplete Apposition | Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image. | 180 days | 
| Late Incomplete Apposition | Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image. | 1 year | 
| Late Incomplete Apposition | Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image. | 2 year | 
| Late Incomplete Apposition | Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image. | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioabsorbable, Coronary Stent, Everolimus, Drug eluting stents, Stents, Angioplasty, Coronary artery disease (CAD), Total coronary occlusion, Coronary artery restenosis, Stent thrombosis, Vascular disease, Myocardial ischemia, Coronary artery stenosis