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ABSORB EXTEND Clinical Investigation (ABSORB EXTEND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01023789
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : December 18, 2017
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

Brief Summary:

The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System

ABSORB BVS is currently in development at Abbott Vascular.


Condition or disease Intervention/treatment Phase
Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis Cardiovascular Disease Device: ABSORB BVS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 812 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
Study Start Date : January 2010
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: ABSORB BVS
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Device: ABSORB BVS
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation



Primary Outcome Measures :
  1. Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [ Time Frame: ≤ 7 days post index procedure (In hospital) ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
    • Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).

  2. Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [ Time Frame: 0 to 30 days ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.

  3. Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [ Time Frame: 0 to 180 days ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).

  4. Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [ Time Frame: 0 to 1 year ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).


Secondary Outcome Measures :
  1. Clinical Device Success [ Time Frame: On day 0 (immediate post-index procedure) ]
    Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis < 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met.

  2. Clinical Procedure Success [ Time Frame: On day 0 (immediate post-index procedure) ]
    Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of < 50% 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. In a dual lesion setting both lesions must meet clinical procedure success.

  3. Number of Participants With Cardiac Death [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  4. Number of Participants With Myocardial Infarction (MI) - Per Protocol [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    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

  5. Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

    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.

  6. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

    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.

  7. Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
  8. Number of Participants With Cardiac Death [ Time Frame: 0 to 30 days ]
    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  9. Number of Participants With Myocardial Infarction (MI) - Per Protocol [ Time Frame: 0 to 30 days ]
    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

  10. Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 0 to 30 days ]

    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.

  11. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 0 to 30 days ]

    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.

  12. Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [ Time Frame: 0 to 30 days ]
  13. Number of Participants With Cardiac Death [ Time Frame: 0 to 180 days ]
    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  14. Number of Participants With Myocardial Infarction (MI) - Per Protocol [ Time Frame: 0 to 180 days ]
    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

  15. Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 0 to 180 days ]

    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.

  16. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 0 to 180 days ]

    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.

  17. Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [ Time Frame: 0 to 180 days ]
  18. Number of Participants With Cardiac Death [ Time Frame: 0 to 1 year ]
    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  19. Number of Participants With Myocardial Infarction (MI) - Per Protocol [ Time Frame: 0 to 1 year ]
    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

  20. Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 0 to 1 year ]

    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. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 0 to 1 year ]

    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.

  22. Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [ Time Frame: 0 to 1 year ]
  23. Number of Participants With Cardiac Death [ Time Frame: 0 to 2 year ]
    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  24. Number of Participants With Myocardial Infarction (MI) - Per Protocol [ Time Frame: 0 to 2 year ]
    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

  25. Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 0 to 2 year ]

    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.

  26. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 0 to 2 year ]

    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. Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [ Time Frame: 0 to 2 year ]
  28. Number of Participants With Cardiac Death [ Time Frame: 0 to 3 years ]
    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  29. Number of Participants With Myocardial Infarction (MI) - Per Protocol [ Time Frame: 0 to 3 years ]
    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

  30. Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 0 to 3 years ]

    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.

  31. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 0 to 3 years ]

    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. Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [ Time Frame: 0 to 3 years ]
  33. Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [ Time Frame: ≤ 7 days post index procedure (In hospital) ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.

  34. Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [ Time Frame: 0 to 30 days ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.

  35. Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [ Time Frame: 0 to 180 days ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.

  36. Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [ Time Frame: 0 to 1 year ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.

  37. Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [ Time Frame: 0 to 2 years ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.

  38. Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [ Time Frame: 0 to 3 years ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.

  39. Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [ Time Frame: 0 to 2 years ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).

  40. Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [ Time Frame: 0 to 3 years ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).

  41. Number of Participants With Scaffold Thrombosis (Early) [ Time Frame: 0 to 30 days ]

    According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.


  42. Number of Participants With Scaffold Thrombosis [ Time Frame: 0 to 180 days ]

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.


  43. Number of Participants With Scaffold Thrombosis (Late) [ Time Frame: 31 - 365 days ]

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.


  44. Number of Participants With Scaffold Thrombosis [ Time Frame: 0 to 1 year ]

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.


  45. Number of Participants With Scaffold Thrombosis (Very Late) [ Time Frame: 366 days to 2 years ]

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.


  46. Number of Participants With Scaffold Thrombosis [ Time Frame: 0 to 2 years ]

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.


  47. Number of Participants With Scaffold Thrombosis [ Time Frame: 0 to 3 years ]

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.


  48. Area Stenosis (%) [ Time Frame: 18 months ]
  49. Minimum Lumen Area [ Time Frame: 18 months ]
  50. Mean Vessel Area [ Time Frame: 18 months ]
  51. Minimum Vessel Area [ Time Frame: 18 months ]
  52. Maximum Vessel Area [ Time Frame: 18 months ]
  53. Mean Lumen Area [ Time Frame: 18 months ]
  54. Maximum Lumen Area [ Time Frame: 18 months ]
  55. Mean Plaque Area [ Time Frame: 18 months ]
  56. Minimum Plaque Area [ Time Frame: 18 months ]
  57. Maximum Plaque Area [ Time Frame: 18 months ]
  58. Mean Reference Area [ Time Frame: 18 months ]
  59. Calculated Minimum Lumen Diameter [ Time Frame: 18 months ]
    The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

  60. Calculated Diameter Stenosis [ Time Frame: 18 months ]
    The value calculated as 100 * (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).



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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
  • Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
  • Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
  • If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (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).
  • Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or if planned to be done 6 months after the index procedure.
  • Percutaneous intervention for lesions in the target vessel are allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure.

Exclusion Criteria:

  • Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
  • Lesion(s) involving a bifurcation with side branch vessel ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.
  • Total occlusion (TIMI flow 0), prior to wire passing.
  • Target vessel(s) contains visible thrombus.
  • Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
  • Subject has received brachytherapy in any epicardial vessel (including side branches).

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): NCT01023789


  Hide Study Locations
Locations
Argentina
Instituto Cardiovascular de Buenos Aires-ICBA
Buenos Aires, Argentina, 1428
Australia, New South Wales
Eastern Heart Clinic, The Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Wesley Hospital
Auchenflower, Queensland, Australia
Australia, Victoria
St. Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Monash Medical Center
Melbourne, Victoria, Australia, 3168
Austria
Allgemeines Krankenhaus Linz
Linz, Austria, 4020
Belgium
Onze-Lieve VrouweZiekenhuis
Aalst, Belgium
Brazil
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
Sao Paulo, Brazil, 04012-180
Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein
Sao Paulo, Brazil, 05652-901
Instituto Coração Triângulo Mineiro
Uberlandia, Brazil, 38400-368
Canada
Montreal Heart Institute
Montreal, Canada, H1T 1C8
University of Ottawa Heart Institute
Ottawa, Canada, K1Y 4W7
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Quebec, Canada, G1V4G5
St. Michael's Hospital
Toronto, Canada, M5B 1W8
China
Prince of Wales Hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Denmark
Århus University Hospital
Århus N, Denmark, 8200
France
Institut Jacques Cartier (ICPS)
Massy, France, 91300
Clinique Pasteur
Toulouse, France, 31076
Hopital De Rangueil - CHU
Toulouse, France, 31403
Germany
Charité Berlin Campus Steglitz
Berlin, Germany, 12203
Uni.Klinikum Heidelberg
Heidelberg, Germany, 69115
India
Apollo Hospital
Hyderabaad, Andhar Pradesh, India, 500033
CARE Hospital
Hyderabaad, Andhra Pradesh, India, 500034
SAL Hospital And Medical Institute
Ahmedabad, India, 380054
Care Institute of Medical Sciences
Ahmedabad, India, 380060
Madras Medical Mission
Chennai, India, 600 037
Medanta -The Medicity
Gurgaon, India, 122001
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, India, 226014
Escorts Heart Institute & Research Centre
New Delhi, India, 110 070
Israel
Rabin Medical Center
Petah Tikva, Israel, 49100
Italy
Catanzaro University Hospital
Catanzaro, Italy, 88100
Centro Cardiologico Monzino
Milano, Italy
Japan
Teikyo University
Tokyo, Itabashi, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Saiseikai Yokohama City Eastern Hospital
Yokohama, Kanagawa, Japan
Kyoto University Hospital
Kyoto, Kansai, Japan
Mitsui Memorial Hospital
Chiyoda-ku, Japan, 101-8643
Malaysia
Institute Jantung Negara
Kuala Lumpur, Malaysia
Netherlands
Catharina ZH Eindhoven
Eindhoven, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
New Zealand
Mercy Angiography Unit
Auckland, New Zealand, 1023
Christchurch Hospital
Christchurch, New Zealand
Poland
University Hospital Krakow
Krakow, Poland, 31-501
Singapore
National University Hospital
Singapore, Singapore, 119228
South Africa
Sunninghill Hospital
Johannesburg, South Africa
Spain
Clinico San Carlos
Madrid, Spain
La Paz
Madrid, Spain
Hospital do Meixoeiro
Pontevedra, Spain, 36200
Sweden
Lund University Hospital
Lund, Sweden, 221 85
Switzerland
Inselspital Bern, Kardiologie
Bern, Switzerland, 3010
Taiwan
Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 83301
National Taiwan University Hospital
Taipei, Taiwan
United Kingdom
Glenfield Hospital
Leicester, United Kingdom
King's College Hospital
London, United Kingdom
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Alexandre Abizaid, MD Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
Study Chair: Patrick Serruys, MD Thoraxcenter-Erasmus University

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

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01023789     History of Changes
Other Study ID Numbers: 09-386
ACTRN12610000131055 ( Registry Identifier: Australian New Zealand Clinical Trials Registry )
REFCTRI000460, 03-05-2010 ( Registry Identifier: Clinical Trials Registry - India )
First Posted: December 2, 2009    Key Record Dates
Results First Posted: December 18, 2017
Last Update Posted: February 14, 2018
Last Verified: December 2017

Keywords provided by Abbott Vascular:
Drug eluting stent
Stents
Angioplasty
Bioabsorbable
Bioresorbable
Scaffold

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes