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XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

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ClinicalTrials.gov Identifier: NCT01721096
Recruitment Status : Active, not recruiting
First Posted : November 5, 2012
Results First Posted : July 19, 2016
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

Brief Summary:
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.

Condition or disease Intervention/treatment
Angina Coronary Occlusion Coronary Artery Disease Coronary Artery Stenosis Myocardial Ischemia Device: XIENCE PRIME - Long Length (LL) Device: XIENCE PRIME - Core Size

Detailed Description:
The primary objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation by Pharmaceuticals and Medical Devices Agency (PMDA).

Study Type : Observational
Actual Enrollment : 536 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: XIENCE PRIME Everolimus Eluting Coronary Stent Post Marketing Surveillance (PMS) in Japan
Study Start Date : October 2012
Actual Primary Completion Date : June 2014
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
XIENCE PRIME - Long Length (LL)
Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length).There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths.
Device: XIENCE PRIME - Long Length (LL)
Long Length
XIENCE PRIME - Core Size
Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths.
Device: XIENCE PRIME - Core Size
Core Size



Primary Outcome Measures :
  1. Number of Participants With Acute Stent Thrombosis (ST) [ Time Frame: Time Frame: Acute (0-24 hours) ]
    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  2. Number of Participants With Subacute Stent Thrombosis (ST) [ Time Frame: Subacute (>24 hours to 30 days) ]
    Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

  3. Number of Participants With Late Stent Thrombosis (ST) [ Time Frame: Late (>30 days to 1 year) ]
    Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

  4. Total Number of Participants With Overall Stent Thrombosis [ Time Frame: 1 year post index procedure ]
    Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).


Secondary Outcome Measures :
  1. Success Rate: Percentage of Participants With Implant Success Rate by Device [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 5 days ]
  2. Success Rate: Percentage of Participants With Procedural Success by Lesion [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 5 days ]
  3. Success Rate: Percentage of Participants With Implant Success by Patient [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 5 days ]
  4. Number of Participants With Target Lesion Failure [ Time Frame: 8 months post index procedure ]
    Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

  5. Number of Participants With Target Lesion Failure [ Time Frame: 1 year post index procedure ]
    Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

  6. Number of Participants With Target Lesion Failure [ Time Frame: 2 year post index procedure ]
    Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

  7. Number of Participants With Target Lesion Failure [ Time Frame: 3 years post index procedure ]
    Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

  8. Number of Participants With All Death/All MI/All Revascularization (DMR) [ Time Frame: 8 months post index procedure ]
  9. Number of Participants With All Death/All MI/All Revascularization (DMR) [ Time Frame: 1 year post index procedure ]
  10. Number of Participants With All Death/All MI/All Revascularization (DMR) [ Time Frame: 2 year post index procedure ]
  11. Number of Participants With All Death/All MI/All Revascularization (DMR) [ Time Frame: 3 year post index procedure ]
  12. Number of Participants With Target Vessel Failure [ Time Frame: 8 months post index procedure ]
    Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

  13. Number of Participants With Target Vessel Failure [ Time Frame: 1 year post index procedure ]
    Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

  14. Number of Participants With Target Vessel Failure [ Time Frame: 2 year post index procedure ]
    Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

  15. Number of Participants With Target Vessel Failure [ Time Frame: 3 year post index procedure ]
    Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

  16. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) [ Time Frame: 8 months 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).

  17. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) [ Time Frame: 1 year 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).

  18. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) [ Time Frame: 2 year 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).

  19. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) [ Time Frame: 3 year 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).

  20. Number of Participants With Death or MI [ Time Frame: 8 months post index procedure ]
  21. Number of Participants With Death or MI [ Time Frame: 1 year post index procedure ]
  22. Number of Participants With Death or MI [ Time Frame: 2 year post index procedure ]
  23. Number of Participants With Death or MI [ Time Frame: 3 year post index procedure ]
  24. Number of Participants With Cardiac Death or MI [ Time Frame: 8 months post index procedure ]
  25. Number of Participants With Cardiac Death or MI [ Time Frame: 1 year post index procedure ]
  26. Number of Participants With Cardiac Death or MI [ Time Frame: 2 year post index procedure ]
  27. Number of Participants With Cardiac Death or MI [ Time Frame: 3 year post index procedure ]
  28. Number of Participants With Cardiac Death or Target Vessel MI [ Time Frame: 8 months post index procedure ]
  29. Number of Participants With Cardiac Death or Target Vessel MI [ Time Frame: 1 year post index procedure ]
  30. Number of Participants With Cardiac Death or Target Vessel MI [ Time Frame: 2 year post index procedure ]
  31. Number of Participants With Cardiac Death or Target Vessel MI [ Time Frame: 3 year post index procedure ]
  32. Number of Participants Experiencing Death [ Time Frame: 8 months post index procedure ]
    Death includes cardiac death, non-cardiac death and non-coronary death.

  33. Number of Participants Experiencing Death [ Time Frame: 1 year post index procedure ]
    Death includes cardiac death, non-cardiac death and non-coronary death.

  34. Number of Participants Experiencing Death [ Time Frame: 2 year post index procedure ]
    Death includes cardiac death, non-cardiac death and non-coronary death.

  35. Number of Participants Experiencing Death [ Time Frame: 3 year post index procedure ]
    Death includes cardiac death, non-cardiac death and non-coronary death.

  36. Number of Participants With Myocardial Infarction [ Time Frame: 8 months post index procedure ]
    The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI

  37. Number of Participants With Myocardial Infarction [ Time Frame: 1 year post index procedure ]
    The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI

  38. Number of Participants With Myocardial Infarction [ Time Frame: 2 year post index procedure ]
    The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI

  39. Number of Participants With Myocardial Infarction [ Time Frame: 3 year post index procedure ]
    The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI

  40. Number of Participants With Target Lesion Revascularization [ Time Frame: 8 months post index procedure ]

    Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.

    Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.


  41. Number of Participants With Target Lesion Revascularization [ Time Frame: 1 year post index procedure ]

    Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.

    Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.


  42. Number of Participants With Target Lesion Revascularization [ Time Frame: 2 year post index procedure ]

    Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.

    Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.


  43. Number of Participants With Target Lesion Revascularization [ Time Frame: 3 year post index procedure ]

    Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.

    Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.


  44. Number of Participants With Target Vessel Revascularization (Non-TLR) [ Time Frame: 8 months post index procedure ]
    Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.

  45. Number of Participants With Target Vessel Revascularization (Non-TLR) [ Time Frame: 1 year post index procedure ]
    Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR

  46. Number of Participants With Target Vessel Revascularization (Non-TLR) [ Time Frame: 2 year post index procedure ]
    Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR

  47. Number of Participants With Target Vessel Revascularization (Non-TLR) [ Time Frame: 3 year post index procedure ]
    Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR

  48. Number of Participants With Target Vessel Revascularization (TLR or TVR Non-TLR) [ Time Frame: 8 months post index procedure ]
    Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

  49. Number of Participants With Target Vessel Revascularization (TLR or TVR Non-TLR) [ Time Frame: 1 year post index procedure ]
    Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

  50. Number of Participants With Target Vessel Revascularization (TLR or TVR Non-TLR) [ Time Frame: 2 year post index procedure ]
    Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

  51. Number of Participants With Target Vessel Revascularization (TLR or TVR Non-TLR) [ Time Frame: 3 year post index procedure ]
    Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

  52. Number of Participants With Non-target Vessel Revascularization (Non-TVR) [ Time Frame: 8 months post index procedure ]
    Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.

  53. Number of Participants With Non-target Vessel Revascularization (Non-TVR) [ Time Frame: 1 year post index procedure ]
    Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.

  54. Number of Participants With Non-target Vessel Revascularization (Non-TVR) [ Time Frame: 2 year post index procedure ]
    Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.

  55. Number of Participants With Non-target Vessel Revascularization (Non-TVR) [ Time Frame: 3 year post index procedure ]
    Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.

  56. Number of Participants With All Revascularization [ Time Frame: 8 months post index procedure ]
    All revascularization includes ischemia driven and non-ischemia driven revascularization.

  57. Number of Participants With All Revascularization [ Time Frame: 1 year post index procedure ]
    All revascularization includes ischemia driven and non-ischemia driven revascularization.

  58. Number of Participants With All Revascularization [ Time Frame: 2 year post index procedure ]
    All revascularization includes ischemia driven and non-ischemia driven revascularization.

  59. Number of Participants With All Revascularization [ Time Frame: 3 year post index procedure ]
    All revascularization includes ischemia driven and non-ischemia driven revascularization.

  60. Number of Participants Experiencing Bleeding [ Time Frame: 8 months post index procedure ]
  61. Number of Participants Experiencing Bleeding [ Time Frame: 1 year post index procedure ]
  62. Number of Participants Experiencing Bleeding [ Time Frame: 2 year post index procedure ]
  63. Number of Participants Experiencing Bleeding [ Time Frame: 3 year post index procedure ]
  64. Percent Diameter Stenosis (%DS) [ Time Frame: Baseline ]
    The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

  65. Percent Diameter Stenosis (%DS) [ Time Frame: Post procedure ]
    The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

  66. Percent Diameter Stenosis (%DS) [ Time Frame: 8 months post index procedure ]
    The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

  67. Acute Gain: In-stent, In-segment [ Time Frame: 8 months post index procedure ]
    The difference between post- and pre-procedural MLD.

  68. Late Loss(LL): In-stent, In-segment, Proximal, and Distal [ Time Frame: 8 months post index procedure ]
    Late loss is calculated as MLD post procedure - MLD at follow-up.

  69. Net Gain: In-stent, In-segment [ Time Frame: 8 months post index procedure ]
    Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).



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:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Only patients in Japan, who are eligible to receive treatment for coronary arteries using the XIENCE PRIME Everolimus-Eluting Stent System are to be enrolled.
Criteria

Inclusion Criteria:

  • Patients with ischemic heart disease who are eligible for treatment with XIENCE PRIME Everolimus Eluting Stent
  • Patient provides Informed Consent Form

Exclusion Criteria:

  • If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.

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): NCT01721096


Locations
Japan
Abbott Vascular Japan Co., Ltd.
Tokyo, Japan, 108-6304
Sponsors and Collaborators
Abbott Vascular
Investigators
Study Chair: Ken Kozuma, MD Teikyo University Hospital, Tokyo

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01721096     History of Changes
Other Study ID Numbers: 12-398
First Posted: November 5, 2012    Key Record Dates
Results First Posted: July 19, 2016
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by Abbott Vascular:
Angioplasty
Drug eluting stents
Stents
Real world

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