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.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.)

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.)

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.)

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.)

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.)

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.)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

Dissection at follow-up that was present post-procedure.

Dissection at follow-up that was present post-procedure.

Dissection at follow-up that was present post-procedure.

Dissection at follow-up that was present post-procedure.

Dissection at follow-up that was present post-procedure.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Vasomotion function was assessed in reaction to nitrate administration.

Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

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.

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.

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.

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.

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.

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.

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.

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.

It is measured during QCA by the Angiographic Core Lab.

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

In Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up

In Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

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.

Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

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.

Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period. Intent-to-treat (ITT) population.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up. Intent-to-treat (ITT) population.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patient (Group 1) lost to follow-up at 4-year follow-up period.

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.

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.