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ABSORB Clinical Investigation, Cohort B (ABSORB B)

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ClinicalTrials.gov Identifier: NCT00856856
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Coronary Disease Coronary Artery Disease Coronary Restenosis Device: Bioabsorbable Everolimus Eluting Coronary Stent Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : March 2009
Actual Primary Completion Date : October 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Absorb stent
Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)
Device: Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease




Primary Outcome Measures :
  1. Hierarchical Major Adverse Cardiac Event (MACE) [ Time Frame: 30 days ]
    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. Hierarchical Major Adverse Cardiac Event (MACE) [ Time Frame: 1 year ]
    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. In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days [ Time Frame: 180 days ]
    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

  4. In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year [ Time Frame: 1 year ]
    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up


Secondary Outcome Measures :
  1. Clinical Device Success (Per Lesion) [ Time Frame: On day 0 (the day of procedure) ]
    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.

  2. Clinical Procedure Success (Per Patient) [ Time Frame: On day 0 (the day of procedure) ]
    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.

  3. Hierarchical Major Adverse Cardiac Event (MACE) [ Time Frame: 180 days ]
    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. Hierarchical Major Adverse Cardiac Event (MACE) [ Time Frame: 270 days ]
    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. Hierarchical Major Adverse Cardiac Event (MACE) [ Time Frame: 2 years ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

  6. Hierarchical Major Adverse Cardiac Event (MACE) [ Time Frame: 3 years ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

  7. Hierarchical Major Adverse Cardiac Event (MACE) [ Time Frame: 4 years ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

  8. Hierarchical Major Adverse Cardiac Event (MACE) [ Time Frame: 5 years ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

  9. Hierarchical Target Vessel Failure (TVF) [ Time Frame: 30 days ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  10. Hierarchical Target Vessel Failure (TVF) [ Time Frame: 180 days ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  11. Hierarchical Target Vessel Failure (TVF) [ Time Frame: 270 days ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  12. Hierarchical Target Vessel Failure (TVF) [ Time Frame: 1 year ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  13. Hierarchical Target Vessel Failure (TVF) [ Time Frame: 2 years ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  14. Hierarchical Target Vessel Failure (TVF) [ Time Frame: 3 years ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  15. Hierarchical Target Vessel Failure (TVF) [ Time Frame: 4 years ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  16. Hierarchical Target Vessel Failure (TVF) [ Time Frame: 5 years ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  17. Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 30 days ]

    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.

  18. Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 180 days ]

    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.

  19. Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 270 days ]

    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.

  20. Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 1 year ]

    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.

  21. Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 2 years ]

    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.

  22. Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 3 years ]

    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.

  23. Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 4 years ]

    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.

  24. Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 5 years ]

    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.

  25. Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 30 days ]

    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.

  26. Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 180 days ]

    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.

  27. Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 270 days ]

    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.

  28. Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 1 year ]

    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.

  29. Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 2 years ]

    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. Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 3 years ]

    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.

  31. Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 4 years ]

    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.

  32. Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 5 years ]

    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.

  33. Cardiac Death [ Time Frame: 30 days ]

    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.)


  34. Cardiac Death [ Time Frame: 1 year ]

    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.)


  35. Cardiac Death [ Time Frame: 2 years ]

    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.)


  36. Cardiac Death [ Time Frame: 3 years ]

    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.)


  37. Cardiac Death [ Time Frame: 4 years ]

    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.)


  38. Cardiac Death [ Time Frame: 5 years ]

    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.)


  39. Myocardial Infarction [ Time Frame: 30 days ]

    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.

  40. Myocardial Infarction [ Time Frame: 1 year ]

    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.

  41. Myocardial Infarction [ Time Frame: 2 years ]

    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.

  42. Myocardial Infarction [ Time Frame: 3 years ]

    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.

  43. Myocardial Infarction [ Time Frame: 4 years ]

    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.

  44. Myocardial Infarction [ Time Frame: 5 years ]

    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.

  45. Scaffold Thrombosis [ Time Frame: 30 days ]

    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.


  46. Scaffold Thrombosis [ Time Frame: 1 year ]

    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.


  47. Scaffold Thrombosis [ Time Frame: 2 years ]

    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.


  48. Scaffold Thrombosis [ Time Frame: 3 years ]

    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.


  49. Scaffold Thrombosis [ Time Frame: 4 years ]

    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.


  50. Scaffold Thrombosis [ Time Frame: 5 years ]

    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.


  51. In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years [ Time Frame: 2 years ]
    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

  52. In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years [ Time Frame: 3 years ]
    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

  53. In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years [ Time Frame: 5 years ]
    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

  54. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days [ Time Frame: 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).

  55. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year [ Time Frame: 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).

  56. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years [ Time Frame: 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).

  57. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years [ Time Frame: 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).

  58. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years [ Time Frame: 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).

  59. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days [ Time Frame: 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).

  60. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year [ Time Frame: 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).

  61. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years [ Time Frame: 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).

  62. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years [ Time Frame: 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).

  63. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years [ Time Frame: 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).

  64. In-scaffold Angiographic Binary Restenosis (ABR) [ Time Frame: 180 days ]
    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

  65. In-scaffold Angiographic Binary Restenosis (ABR) [ Time Frame: 1 year ]
    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

  66. In-scaffold Angiographic Binary Restenosis (ABR) [ Time Frame: 2 years ]
    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

  67. In-scaffold Angiographic Binary Restenosis (ABR) [ Time Frame: 3 years ]
    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

  68. In-scaffold Angiographic Binary Restenosis (ABR) [ Time Frame: 5 years ]
    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

  69. Persisting Dissection [ Time Frame: 180 days ]
    Dissection at follow-up that was present post-procedure.

  70. Persisting Dissection [ Time Frame: 1 year ]
    Dissection at follow-up that was present post-procedure.

  71. Persisting Dissection [ Time Frame: 2 years ]
    Dissection at follow-up that was present post-procedure.

  72. Persisting Dissection [ Time Frame: 3 years ]
    Dissection at follow-up that was present post-procedure.

  73. Persisting Dissection [ Time Frame: 5 years ]
    Dissection at follow-up that was present post-procedure.

  74. In-scaffold Percent Diameter Stenosis (%DS) [ Time Frame: 180 days ]
    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.

  75. In-scaffold Percent Diameter Stenosis (%DS) [ Time Frame: 1 year ]
    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.

  76. In-scaffold Percent Diameter Stenosis (%DS) [ Time Frame: 2 years ]
    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.

  77. In-scaffold Percent Diameter Stenosis (%DS) [ Time Frame: 3 years ]
    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.

  78. In-scaffold Percent Diameter Stenosis (%DS) [ Time Frame: 5 years ]
    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.

  79. Aneurysm [ Time Frame: 180 days ]
    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.

  80. Aneurysm [ Time Frame: 1 year ]
    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.

  81. Aneurysm [ Time Frame: 2 years ]
    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.

  82. Aneurysm [ Time Frame: 3 years ]
    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.

  83. Aneurysm [ Time Frame: 5 years ]
    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.

  84. Thrombus [ Time Frame: 180 days ]
  85. Thrombus [ Time Frame: 1 year ]
  86. Thrombus [ Time Frame: 2 years ]
  87. Thrombus [ Time Frame: 3 years ]
  88. Thrombus [ Time Frame: 5 years ]
  89. Vasomotion Analysis: In-scaffold Mean Luminal Diameter [ Time Frame: 5 years ]
    Vasomotion function was assessed in reaction to nitrate administration.

  90. Volume Obstruction (VO) [ Time Frame: 180 days ]
    Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

  91. Volume Obstruction (VO) [ Time Frame: 1 year ]
    Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

  92. Volume Obstruction (VO) [ Time Frame: 2 year ]
    Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

  93. Volume Obstruction (VO) [ Time Frame: 3 year ]
    Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

  94. Persisting Incomplete Apposition [ Time Frame: 180 days ]

    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.


  95. Persisting Incomplete Apposition [ Time Frame: 1 year ]

    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.


  96. Persisting Incomplete Apposition [ Time Frame: 2 year ]

    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.


  97. Persisting Incomplete Apposition [ Time Frame: 3 year ]

    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.


  98. Late Incomplete Apposition [ Time Frame: 180 days ]

    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.


  99. Late Incomplete Apposition [ Time Frame: 1 year ]

    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.


  100. Late Incomplete Apposition [ Time Frame: 2 year ]

    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.


  101. Late Incomplete Apposition [ Time Frame: 3 year ]

    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.



Other Outcome Measures:
  1. Mean Reference Area [ Time Frame: 1 year ]
  2. Mean Reference Area [ Time Frame: 2 years ]
  3. Mean Reference Area [ Time Frame: 3 years ]
  4. Mean Reference Area [ Time Frame: 5 years ]
  5. Mean Luminal Area [ Time Frame: 1 year ]
  6. Mean Luminal Area [ Time Frame: 2 years ]
  7. Mean Luminal Area [ Time Frame: 3 years ]
  8. Mean Luminal Area [ Time Frame: 5 years ]
  9. Minimum Luminal Area [ Time Frame: 1 year ]
  10. Minimum Luminal Area [ Time Frame: 2 years ]
  11. Minimum Luminal Area [ Time Frame: 3 years ]
  12. Minimum Luminal Area [ Time Frame: 5 years ]
  13. Mean Stent Area [ Time Frame: 1 year ]
  14. Mean Scaffold Area [ Time Frame: 2 years ]
  15. Mean Scaffold Area [ Time Frame: 3 years ]
  16. Minimum Stent Area [ Time Frame: 1 year ]
  17. Minimum Scaffold Area [ Time Frame: 2 year ]
  18. Minimum Scaffold Area [ Time Frame: 3 years ]
  19. Luminal Volume [ Time Frame: 1 year ]
  20. Luminal Volume [ Time Frame: 2 years ]
  21. Luminal Volume [ Time Frame: 3 years ]
  22. Luminal Volume [ Time Frame: 5 years ]
  23. Stent Volume [ Time Frame: 1 year ]
  24. Scaffold Volume [ Time Frame: 2 years ]
  25. Scaffold Volume [ Time Frame: 3 years ]
  26. Mean Luminal Diameter [ Time Frame: 1 year ]
  27. Mean Luminal Diameter [ Time Frame: 2 years ]
  28. Mean Luminal Diameter [ Time Frame: 3 years ]
  29. Mean Luminal Diameter [ Time Frame: 5 years ]
    It is measured during QCA by the Angiographic Core Lab.

  30. Minimum Luminal Diameter (MLD) [ Time Frame: 1 year ]
    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.

  31. Minimum Luminal Diameter [ Time Frame: 2 years ]
    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.

  32. Minimum Luminal Diameter [ Time Frame: 3 years ]
    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.

  33. Minimum Luminal Diameter [ Time Frame: 5 years ]
    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.

  34. Mean Stent Diameter [ Time Frame: 1 year ]
  35. Mean Scaffold Diameter [ Time Frame: 2 years ]
  36. Mean Scaffold Diameter [ Time Frame: 3 years ]
  37. Minimum Stent Diameter [ Time Frame: 1 year ]
  38. Minimum Scaffold Diameter [ Time Frame: 2 years ]
  39. Minimum Scaffold Diameter [ Time Frame: 3 years ]
  40. Strut Volume [ Time Frame: 1 year ]
  41. Strut Volume [ Time Frame: 2 years ]
  42. Strut Volume [ Time Frame: 3 years ]
  43. Number of Struts Per BVS [ Time Frame: 1 year ]
  44. Number of Struts Per BVS [ Time Frame: 2 years ]
  45. Number of Struts Per BVS [ Time Frame: 3 years ]
  46. Number of Struts Per BVS [ Time Frame: 5 years ]
  47. % of Covered Struts (150 µm) [ Time Frame: 1 year ]
  48. % of Acutely Covered Struts [ Time Frame: 2 years ]
  49. % of Acutely Covered Struts [ Time Frame: 3 years ]
  50. % of Uncovered Struts (150 µm) [ Time Frame: 1 year ]
  51. % of Uncovered Struts (150 µm) [ Time Frame: 2 years ]
  52. % of Uncovered Struts (150 µm) [ Time Frame: 3 years ]
  53. Number of Struts in Side Branch [ Time Frame: 1 year ]
  54. Number of Struts in Side Branch [ Time Frame: 2 years ]
  55. Number of Struts in Side Branch [ Time Frame: 3 years ]
  56. Number of Struts in Side Branch [ Time Frame: 5 years ]
  57. Tissue Coverage Area Classical [ Time Frame: 1 year ]
  58. Tissue Coverage Area BVS (Neointimal Area) [ Time Frame: 1 year ]
  59. Tissue Coverage Volume Classical [ Time Frame: 1 year ]
  60. Tissue Coverage Volume BVS [ Time Frame: 1 year ]
  61. Tissue Coverage Obstruction Volume Classical [ Time Frame: 1 year ]
  62. Tissue Coverage Obstruction Volume BVS [ Time Frame: 1 year ]
  63. Tissue Coverage Area Classical [ Time Frame: 2 years ]
  64. Tissue Coverage Area BVS (Neointimal Area) [ Time Frame: 2 years ]
  65. Tissue Coverage Volume Classical [ Time Frame: 2 years ]
  66. Tissue Coverage Volume BVS [ Time Frame: 2 years ]
  67. Tissue Coverage Obstruction Volume Classical [ Time Frame: 2 years ]
  68. Tissue Coverage Obstruction Volume BVS [ Time Frame: 2 years ]
  69. Tissue Coverage Area Classical [ Time Frame: 3 years ]
  70. Tissue Coverage Area BVS (Neointimal Area) [ Time Frame: 3 years ]
  71. Tissue Coverage Volume Classical [ Time Frame: 3 years ]
  72. Tissue Coverage Volume BVS [ Time Frame: 3 years ]
  73. Tissue Coverage Obstruction Volume Classical [ Time Frame: 3 years ]
  74. Tissue Coverage Obstruction Volume BVS [ Time Frame: 3 years ]
  75. Mean Flow Area [ Time Frame: 1 year ]
  76. Minimum Flow Area [ Time Frame: 1 year ]
  77. Mean Strut Core Area [ Time Frame: 1 year ]
  78. Percent (%) Lumen Area Stenosis [ Time Frame: 1 year ]
  79. Mean Flow Area [ Time Frame: 2 years ]
  80. Minimum Flow Area [ Time Frame: 2 years ]
  81. Mean Strut Core Area [ Time Frame: 2 years ]
  82. Percent (%) Lumen Area Stenosis [ Time Frame: 2 years ]
  83. Mean Flow Area [ Time Frame: 3 years ]
  84. Minimum Flow Area [ Time Frame: 3 years ]
  85. Mean Strut Core Area [ Time Frame: 3 years ]
  86. Percent (%) Lumen Area Stenosis [ Time Frame: 3 years ]
  87. Mean Flow Area [ Time Frame: 5 years ]
  88. Minimum Flow Area [ Time Frame: 5 years ]
  89. Percent (%) Lumen Area Stenosis [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General inclusion criteria

  1. Patient must be at least 18 years of age.
  2. 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.
  3. 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)
  4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
  5. 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)
  6. Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure

Angiographic Inclusion Criteria

  1. Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm
  2. Target lesion(s) must measure ≤ 14 mm in length by visual estimation
  3. 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
  4. 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
  5. If two target lesion(s) are being treated, each of these lesions must meet all angiographic inclusion/exclusion criteria
  6. 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
  7. 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

  1. 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
  2. The patient is currently experiencing clinical symptoms consistent with AMI
  3. Patient has current unstable arrhythmias
  4. Patient has a known left ventricular ejection fraction (LVEF) < 30%
  5. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
  6. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
  7. Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
  8. Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
  9. 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
  10. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
  11. 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)
  12. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
  13. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  14. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
  15. Patient has had a significant GI or urinary bleed within the past six months
  16. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
  17. 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)
  18. Patient is already participating in another clinical investigation that has not yet reached its primary endpoint
  19. 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)
  20. Patient has received brachytherapy in any epicardial vessel (including side branches)

Angiographic Exclusion Criteria

  1. Target lesion(s) meets any of the following criteria:

    1. Aorto-ostial location (within 3 mm)
    2. Left main location
    3. Located within 2 mm of the origin of the LAD or LCX
    4. 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
    5. Lesion involving a bifurcation ≥ 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
    6. Total occlusion (TIMI flow 0), prior to wire crossing
    7. Excessive tortuosity proximal to or within the lesion
    8. Extreme angulation (≥ 90%) proximal to or within the lesion
    9. Heavy calcification
    10. Restenotic from previous intervention
  2. The target vessel contains visible thrombus
  3. Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches)
  4. 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856856


Locations
Layout table for location information
Australia, Victoria
St. Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Australia
Monash Heart
Melbourne, Australia
Belgium
Onze-Lieve VrouweZiekenhuis
Aalst, Belgium
Denmark
Skejby Sygehus
Aarhus, Denmark
France
Institut Hospitalier Jacques Cartier
Massy, France
Netherlands
Catharina ZH Eindhoven
Eindhoven, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
New Zealand
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Poland
Jagiellonian University
Krakow, Poland
Switzerland
Inselspital Bern, Kardiologie
Bern, Switzerland, 3010
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Principal Investigator: Patrick Serruys, MD Erasmus Heart Center, Thorax Centrum
Principal Investigator: John Ormiston, MD Auckland City Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00856856     History of Changes
Other Study ID Numbers: 05-370 Cohort B
First Posted: March 6, 2009    Key Record Dates
Results First Posted: February 7, 2019
Last Update Posted: February 7, 2019
Last Verified: January 2018
Keywords provided by Abbott Medical Devices:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents