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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
St. Vincent's Hospital
Melbourne, Victoria, Australia
Monash Heart
Melbourne, Australia
Onze-Lieve VrouweZiekenhuis
Aalst, Belgium
Skejby Sygehus
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).
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 1 year
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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Aarhus, Denmark
Institut Hospitalier Jacques Cartier
Massy, France
Catharina ZH Eindhoven
Eindhoven, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
...and 2 more locations
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 5 years
In-scaffold Angiographic Binary Restenosis (ABR)
Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.
Time frame: 180 days
In-scaffold Angiographic Binary Restenosis (ABR)
Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.
Time frame: 1 year
In-scaffold Angiographic Binary Restenosis (ABR)
Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.
Time frame: 2 years
In-scaffold Angiographic Binary Restenosis (ABR)
Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.
Time frame: 3 years
In-scaffold Angiographic Binary Restenosis (ABR)
Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.
Time frame: 5 years
Persisting Dissection
Dissection at follow-up that was present post-procedure.
Time frame: 180 days
Persisting Dissection
Dissection at follow-up that was present post-procedure.
Time frame: 1 year
Persisting Dissection
Dissection at follow-up that was present post-procedure.
Time frame: 2 years
Persisting Dissection
Dissection at follow-up that was present post-procedure.
Time frame: 3 years
Persisting Dissection
Dissection at follow-up that was present post-procedure.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
Thrombus
Time frame: 180 days
Thrombus
Time frame: 1 year
Thrombus
Time frame: 2 years
Thrombus
Time frame: 3 years
Thrombus
Time frame: 5 years
Vasomotion Analysis: In-scaffold Mean Luminal Diameter
Vasomotion function was assessed in reaction to nitrate administration.
Time frame: 5 years
Volume Obstruction (VO)
Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Time frame: 180 days
Volume Obstruction (VO)
Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Time frame: 1 year
Volume Obstruction (VO)
Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Time frame: 2 year
Volume Obstruction (VO)
Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 year