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

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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 Vascular

March 11, 2010
March 15, 2010
February 13, 2017
February 19, 2018
February 19, 2018
March 2010
June 2012   (Final data collection date for primary outcome measure)
  • 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

  • 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

  • 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

  • (This study has no primary outcome measure. All observations are of equal weight) Stent thrombosis as per ARC definition. [ Time Frame: 1, 2, 3, 4, and 5 years post index procedure ]
  • Information on and the frequency of adverse events caused by antiplatelet therapy [ Time Frame: 1, 2, 3, 4, and 5 years post index procedure ]
Complete list of historical versions of study NCT01086228 on ClinicalTrials.gov Archive Site
  • Number of Participants With Adverse Events Related to Anti-platelet Medication [ Time Frame: From post-procedure to 1 year ]
  • Number of Participants With Adverse Events Related to Anti-platelet Medication [ Time Frame: From 1 year to 2 years ]
  • Number of Participants With Adverse Events Related to Anti-platelet Medication [ Time Frame: From 2 years to 3 years ]
  • Number of Participants With Adverse Events Related to Anti-platelet Medication [ Time Frame: From 3 years to 4 years ]
  • Number of Participants With Adverse Events Related to Anti-platelet Medication [ Time Frame: From 4 years to 5 years ]
  • 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).
  • 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).
  • 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).
  • 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).
  • 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].
  • Net Gain [ Time Frame: On day 0 after procedure ]
    Net Gain = Acute Gain - Late Loss, paired analysis only.
  • 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.
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.
  • 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.
  • 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.
  • 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.

  • 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.

  • 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.

  • Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: Post Procedure to 1 Year ]
  • Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: From 1 Year to 2 Years ]
  • Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: From 2 Years to 3 Years ]
  • Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR [ Time Frame: Post Procedure to 1 Year ]
  • Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR [ Time Frame: From 1 Year to 2 Years ]
  • Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR [ Time Frame: From 2 Years to 3 Years ]
  • Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) [ Time Frame: Post Procedure to 1 Year ]
  • Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) [ Time Frame: From 1 Year to 2 Years ]
  • Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) [ Time Frame: From 2 Years to 3 Years ]
  • Number of Participants With All Deaths and All MI [ Time Frame: Post Procedure to 1 Year ]
  • Number of Participants With All Deaths and All MI [ Time Frame: From 1 Year to 2 Years ]
  • Number of Participants With All Deaths and All MI [ Time Frame: From 2 Years to 3 Years ]
  • Number of Participants With All Deaths, All MI and All Revascularization [ Time Frame: Post Procedure to 1 Year ]
  • Number of Participants With All Deaths, All MI and All Revascularization [ Time Frame: From 1 Year to 2 Years ]
  • Number of Participants With All Deaths, All MI and All Revascularization [ Time Frame: From 2 Years to 3 Years ]
  • Number of Participants With All Deaths, TVMI and TLR [ Time Frame: Post Procedure to 1 Year ]
  • Number of Participants With All Deaths, TVMI and TLR [ Time Frame: From 1 Year to 2 Years ]
  • Number of Participants With All Deaths, TVMI and TLR [ Time Frame: From 2 Years to 3 Years ]
  • Number of Participants With All Deaths, TVMI and CI-TLR [ Time Frame: Post Procedure to 1 Year ]
  • Number of Participants With All Deaths, TVMI and CI-TLR [ Time Frame: From 1 Year to 2 Years ]
  • Number of Participants With All Deaths, TVMI and CI-TLR [ Time Frame: From 2 Years to 3 Years ]
  • Composite rate of cardiac death and any MI (Q wave or Non-Q wave) [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ]
  • Composite rate of any death and any MI (QMI or NQMI) [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ]
  • Composite rate of any death, any MI (QMI or NQMI), and any coronary repeat revascularization (PCI or CABG, clinically indicated [CI] vs. non-clinically indicated [non-CI]) [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ]
  • Composite rate of cardiac death, any target vessel MI (QMI or NQMI), and TLR (PCI or CABG, CI vs. non-CI) [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ]
  • Any death (cardiac death, vascular death, or non-cardiovascular death) [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ]
  • Any MI (QMI or NQMI) [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ]
  • Any repeat coronary revascularization (TLR, TVR, or non-target vessel TVR by PCI or CABG, CI vs. non-CI) [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ]
  • Administration and discontinuation of predefined antiplatelet therapy [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ]
  • Device malfunctions [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ]
  • Serious adverse events [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ]
  • Reference vessel diameter (RVD) and minimal lumen diameter (MLD) and % diameter stenosis (DS) [ Time Frame: pre-procedure and post-procedure ]
  • In-stent late loss (LL) and in-stent % DS [ Time Frame: 240 days ]
  • In-segment LL and in-segment % DS [ Time Frame: 240 days ]
Not Provided
Not Provided
 
XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
XIENCE V/PROMUS Everolimus-Eluting Stent System Japan Post-marketing Surveillance Protocol
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.
The surveillance is to be conducted in accordance with the Japanese Ministerial Ordinance concerning the Standards for Postmarketing Surveillance and Tests of Medical Devices.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
  • 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
Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
XIENCE V / PROMUS stent
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
Intervention: Device: XIENCE V / PROMUS stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2010
2000
August 2016
June 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01086228
09-384
No
Not Provided
Not Provided
Abbott Vascular
Abbott Vascular
Not Provided
Study Director: Gary Thompson Abbott Vascular
Abbott Vascular
August 2017