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XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan

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: NCT01086228
Recruitment Status : Completed
First Posted : March 15, 2010
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:
The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.

Condition or disease Intervention/treatment
Angina Chronic Coronary Occlusion Stent Thrombosis Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis Device: XIENCE V / PROMUS stent

Detailed Description:
The surveillance is to be conducted in accordance with the Japanese Ministerial Ordinance concerning the Standards for Postmarketing Surveillance and Tests of Medical Devices.
Study Design
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Study Type : Observational
Actual Enrollment : 2010 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: XIENCE V/PROMUS Everolimus-Eluting Stent System Japan Post-marketing Surveillance Protocol
Study Start Date : March 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
XIENCE V / PROMUS stent
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
 Device: XIENCE V / PROMUS stent
Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Stent Thrombosis (ST) as Per ARC Definition [ Time Frame: Post Procedure to 1 Year ]

    Definite ST occurred by either angiographic/pathologic confirmation of ST.

    Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:

    • Acute onset of ischemic symptoms at rest
    • New ischemic ECG changes
    • Typical rise&fall in cardiac biomarkers
    • Non-occlusive &occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.

    Probable ST may occur due to:

    • Unexplained death within first 30 days
    • Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause.

    Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up


  2. Number of Participants With Stent Thrombosis (ST) as Per ARC Definition [ Time Frame: From 1 Year to 2 Years ]

    Definite ST occurred by either angiographic/pathologic confirmation of ST.

    Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:

    • Acute onset of ischemic symptoms at rest
    • New ischemic ECG changes
    • Typical rise&fall in cardiac biomarkers
    • Non-occlusive &occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.

    Probable ST may occur due to:

    • Unexplained death within first 30 days
    • Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause.

    Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up


  3. Number of Participants With Stent Thrombosis (ST) as Per ARC Definition [ Time Frame: From 2 years to 3 years ]

    Definite ST occurred by either angiographic/pathologic confirmation of ST.

    Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:

    • Acute onset of ischemic symptoms at rest
    • New ischemic ECG changes
    • Typical rise&fall in cardiac biomarkers
    • Non-occlusive &occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.

    Probable ST may occur due to:

    • Unexplained death within first 30 days
    • Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause.

    Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up



Secondary Outcome Measures :
  1. Number of Participants With Adverse Events Related to Anti-platelet Medication [ Time Frame: From post-procedure to 1 year ]
  2. Number of Participants With Adverse Events Related to Anti-platelet Medication [ Time Frame: From 1 year to 2 years ]
  3. Number of Participants With Adverse Events Related to Anti-platelet Medication [ Time Frame: From 2 years to 3 years ]
  4. Number of Participants With Adverse Events Related to Anti-platelet Medication [ Time Frame: From 3 years to 4 years ]
  5. Number of Participants With Adverse Events Related to Anti-platelet Medication [ Time Frame: From 4 years to 5 years ]
  6. Percent Diameter Stenosis (%DS) [ Time Frame: Baseline ]
    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

  7. Percent Diameter Stenosis (%DS) [ Time Frame: On day 0 after procedure ]
    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

  8. Percent Diameter Stenosis (%DS) [ Time Frame: At 8 months ]
    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

  9. Acute Gain [ Time Frame: On day 0 after procedure ]
    The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).

  10. Late Loss [ Time Frame: On day 0 after procedure ]
    Proximal and distal late loss was calculated by [post-procedure minimum lumen diameter (MLD)] - [MLD at 8 months].

  11. Net Gain [ Time Frame: On day 0 after procedure ]
    Net Gain = Acute Gain - Late Loss, paired analysis only.

  12. Acute Success [ Time Frame: On day 0 (Immediately post-index procedure) ]

    Acute Success: Procedural Success (Subject Level Analysis): Stent implant procedure was considered successful when all of the following criteria were met:

    • Stent was successfully delivered to the intended location
    • Stent was successfully deployed at the intended location
    • Stent delivery system was withdrawn without any issue Stent implantation procedure was considered successful in 99.94% of the stents. There was no stent adjudicated as procedure failure.

  13. Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death) [ Time Frame: Post Procedure to 1 Year ]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    • Cardiac death: 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.

    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.


  14. Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death) [ Time Frame: From 1 to 2 years ]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    • Cardiac death: 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.

    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.


  15. Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death) [ Time Frame: From 2 years to 3 years ]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    • Cardiac death: 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.

    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.


  16. Number of Participants With Myocardial Infarctions (MI) [ Time Frame: Post Procedure to 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.


  17. Number of Participants With Myocardial Infarctions (MI) [ Time Frame: From 1 year to 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.


  18. Number of Participants With Myocardial Infarctions (MI) [ Time Frame: From 2 years to 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.


  19. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: Post Procedure to 1 Year ]

    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. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  20. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: From 1 year to 2 years ]

    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. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  21. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: From 2 years to 3 years ]

    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. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  22. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: Post Procedure to 1 Year ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  23. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: From 1 Year to 2 Years ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  24. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: From 2 Years to 3 Years ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  25. Number of Participants With Cardiac Death and All MI [ Time Frame: Post Procedure to 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.)

    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.


  26. Number of Participants With Cardiac Death and All MI [ Time Frame: From 1 Year to 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.)

    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.


  27. Number of Participants With Cardiac Death and All MI [ Time Frame: From 2 Years to 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.)

    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.


  28. Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: Post Procedure to 1 Year ]
  29. Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: From 1 Year to 2 Years ]
  30. Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: From 2 Years to 3 Years ]
  31. Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR [ Time Frame: Post Procedure to 1 Year ]
  32. Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR [ Time Frame: From 1 Year to 2 Years ]
  33. Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR [ Time Frame: From 2 Years to 3 Years ]
  34. Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) [ Time Frame: Post Procedure to 1 Year ]
  35. Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) [ Time Frame: From 1 Year to 2 Years ]
  36. Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) [ Time Frame: From 2 Years to 3 Years ]
  37. Number of Participants With All Deaths and All MI [ Time Frame: Post Procedure to 1 Year ]
  38. Number of Participants With All Deaths and All MI [ Time Frame: From 1 Year to 2 Years ]
  39. Number of Participants With All Deaths and All MI [ Time Frame: From 2 Years to 3 Years ]
  40. Number of Participants With All Deaths, All MI and All Revascularization [ Time Frame: Post Procedure to 1 Year ]
  41. Number of Participants With All Deaths, All MI and All Revascularization [ Time Frame: From 1 Year to 2 Years ]
  42. Number of Participants With All Deaths, All MI and All Revascularization [ Time Frame: From 2 Years to 3 Years ]
  43. Number of Participants With All Deaths, TVMI and TLR [ Time Frame: Post Procedure to 1 Year ]
  44. Number of Participants With All Deaths, TVMI and TLR [ Time Frame: From 1 Year to 2 Years ]
  45. Number of Participants With All Deaths, TVMI and TLR [ Time Frame: From 2 Years to 3 Years ]
  46. Number of Participants With All Deaths, TVMI and CI-TLR [ Time Frame: Post Procedure to 1 Year ]
  47. Number of Participants With All Deaths, TVMI and CI-TLR [ Time Frame: From 1 Year to 2 Years ]
  48. Number of Participants With All Deaths, TVMI and CI-TLR [ Time Frame: From 2 Years to 3 Years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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 V / PROMUS Everolimus-Eluting Stent System are to be enrolled.
Criteria

Inclusion Criteria:

  • Only XIENCE V stent(s)or PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.

Exclusion Criteria:

  • Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
Contacts and Locations
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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): NCT01086228


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Study Director: Gary Thompson Abbott Medical Devices
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01086228    
Other Study ID Numbers: 09-384
First Posted: March 15, 2010    Key Record Dates
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018
Last Verified: August 2017
Keywords provided by Abbott Medical Devices:
Drug eluting stents
Stents
Angioplasty
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Thrombosis
Vascular Diseases
Coronary Stenosis
Coronary Occlusion
Coronary Restenosis
 Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Embolism and Thrombosis