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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Disease; Stent Thrombosis; Coronary Restenosis; Chronic Coronary Occlusion; Vascular Disease; Coronary Artery Stenosis; Angina
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 2010

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
    • Site Reference ID/Investigator# 104727
  • Aichi, Japan
    • Site Reference ID/Investigator# 113428
  • Aichi, Japan
    • Site Reference ID/Investigator# 115745
  • Chiba, Japan
    • Site Reference ID/Investigator# 104424
  • Chiba, Japan
    • Site Reference ID/Investigator# 113645
  • Ehime, Japan
    • Site Reference ID/Investigator# 105015
  • Fukuoka, Japan
    • Site Reference ID/Investigator# 105148
  • Fukuoka, Japan
    • Site Reference ID/Investigator# 105177
  • Gifu, Japan
    • Site Reference ID/Investigator# 104677
  • Gunma, Japan
    • Site Reference ID/Investigator# 104365
  • Hiroshima, Japan
    • Site Reference ID/Investigator# 105038
  • Hiroshima, Japan
    • Site Reference ID/Investigator# 105043
  • Hokkaido, Japan
    • Site Reference ID/Investigator# 104236
  • Hyogo, Japan
    • Site Reference ID/Investigator# 105963
  • Ibaraki, Japan
    • Site Reference ID/Investigator# 104326
  • Ishikawa, Japan
    • Site Reference ID/Investigator# 104606
  • Ishikawa, Japan
    • Site Reference ID/Investigator# 104607
  • Kanagawa, Japan
    • Site Reference ID/Investigator# 104528
  • Kanagawa, Japan
    • Site Reference ID/Investigator# 104536
  • Kanagawa, Japan
    • Site Reference ID/Investigator#104563
  • Kyoto, Japan
    • Site Reference ID/Investigator# 104837
  • Kyoto, Japan
    • Site Reference ID/Investigator# 104838
  • Kyoto, Japan
    • Site Reference ID/Investigator# 104843
  • Kyoto, Japan
    • Site Reference ID/Investigator# 104844
  • Kyoto, Japan
    • Site Reference ID/Investigator# 104850
  • Nagano, Japan
    • Site Reference ID/Investigator# 104658
  • Nara, Japan
    • Site Reference ID/Investigator# 104990
  • Okayama, Japan
    • Site Reference ID/Investigator# 105027
  • Okinawa, Japan
    • Site Reference ID/Investigator# 105296
  • Osaka, Japan
    • Site Reference ID/Investigator# 104864
  • Osaka, Japan
    • Site Reference ID/Investigator# 104898
  • Osaka, Japan
    • Site Reference ID/Investigator# 104906
  • Osaka, Japan
    • Site Reference ID/Investigator# 114863
  • Saitama, Japan
    • Site Reference ID/Investigator# 104407
  • Saitama, Japan
    • Site Reference ID/Investigator# 106044
  • Shizuoka, Japan
    • Site Reference ID/Investigator# 104697
  • Tochigi, Japan
    • Site Reference ID/Investigator# 104356
  • Tokushima, Japan
    • Site Reference ID/Investigator# 105092
  • Tokyo, Japan
    • Site Reference ID/Investigator# 104448
  • Tokyo, Japan
    • Site Reference ID/Investigator# 104454
  • Tokyo, Japan
    • Site Reference ID/Investigator# 104473
  • Tokyo, Japan
    • Site Reference ID/Investigator# 104497
  • Tokyo, Japan
    • Site Reference ID/Investigator# 104510
  • Tokyo, Japan
    • Site Reference ID/Investigator# 104514
  • Tokyo, Japan
    • Site Reference ID/Investigator#104481
  • Yamagata, Japan
    • Site Reference ID/Investigator # 104285
  • Yamagata, Japan
    • Site Reference ID/Investigator# 104294

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition	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	Post Procedure to 1 Year
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition	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	From 1 Year to 2 Years
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition	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	From 2 years to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events Related to Anti-platelet Medication		From post-procedure to 1 year
Number of Participants With Adverse Events Related to Anti-platelet Medication		From 1 year to 2 years
Number of Participants With Adverse Events Related to Anti-platelet Medication		From 2 years to 3 years
Number of Participants With Adverse Events Related to Anti-platelet Medication		From 3 years to 4 years
Number of Participants With Adverse Events Related to Anti-platelet Medication		From 4 years to 5 years
Percent Diameter Stenosis (%DS)	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).	Baseline
Percent Diameter Stenosis (%DS)	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).	On day 0 after procedure
Percent Diameter Stenosis (%DS)	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).	At 8 months
Acute Gain	The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).	On day 0 after procedure
Late Loss	Proximal and distal late loss was calculated by [post-procedure minimum lumen diameter (MLD)] - [MLD at 8 months].	On day 0 after procedure
Net Gain	Net Gain = Acute Gain - Late Loss, paired analysis only.	On day 0 after procedure
Acute Success	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.	On day 0 (Immediately post-index procedure)
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)	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.	Post Procedure to 1 Year
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)	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.	From 1 to 2 years
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)	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.	From 2 years to 3 years
Number of Participants With Myocardial Infarctions (MI)	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.	Post Procedure to 1 Year
Number of Participants With Myocardial Infarctions (MI)	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.	From 1 year to 2 years
Number of Participants With Myocardial Infarctions (MI)	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.	From 2 years to 3 years
Number of Participants With Target Lesion Revascularization (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. 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.	Post Procedure to 1 Year
Number of Participants With Target Lesion Revascularization (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. 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.	From 1 year to 2 years
Number of Participants With Target Lesion Revascularization (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. 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.	From 2 years to 3 years
Number of Participants With Target Vessel Revascularization (TVR)	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.	Post Procedure to 1 Year
Number of Participants With Target Vessel Revascularization (TVR)	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.	From 1 Year to 2 Years
Number of Participants With Target Vessel Revascularization (TVR)	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.	From 2 Years to 3 Years
Number of Participants With Cardiac Death and All MI	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.	Post Procedure to 1 Year
Number of Participants With Cardiac Death and All MI	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.	From 1 Year to 2 Years
Number of Participants With Cardiac Death and All MI	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.	From 2 Years to 3 Years
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)		Post Procedure to 1 Year
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)		From 1 Year to 2 Years
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)		From 2 Years to 3 Years
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR		Post Procedure to 1 Year
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR		From 1 Year to 2 Years
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR		From 2 Years to 3 Years
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)		Post Procedure to 1 Year
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)		From 1 Year to 2 Years
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)		From 2 Years to 3 Years
Number of Participants With All Deaths and All MI		Post Procedure to 1 Year
Number of Participants With All Deaths and All MI		From 1 Year to 2 Years
Number of Participants With All Deaths and All MI		From 2 Years to 3 Years
Number of Participants With All Deaths, All MI and All Revascularization		Post Procedure to 1 Year
Number of Participants With All Deaths, All MI and All Revascularization		From 1 Year to 2 Years
Number of Participants With All Deaths, All MI and All Revascularization		From 2 Years to 3 Years
Number of Participants With All Deaths, TVMI and TLR		Post Procedure to 1 Year
Number of Participants With All Deaths, TVMI and TLR		From 1 Year to 2 Years
Number of Participants With All Deaths, TVMI and TLR		From 2 Years to 3 Years
Number of Participants With All Deaths, TVMI and CI-TLR		Post Procedure to 1 Year
Number of Participants With All Deaths, TVMI and CI-TLR		From 1 Year to 2 Years
Number of Participants With All Deaths, TVMI and CI-TLR		From 2 Years to 3 Years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Gary Thompson, Abbott Medical Devices

Publications and helpful links

General Publications

• Aoki J, Kozuma K, Awata M, Nanasato M, Shiode N, Tanabe K, Yamaguchi J, Kusano H, Nie H, Kimura T; XIEVCE V/PROMUS PMS Investigators. Five-year clinical outcomes of everolimus-eluting stents from the post marketing study of CoCr-EES (XIENCE V/PROMUS) in Japan. Cardiovasc Interv Ther. 2019 Jan;34(1):40-46. doi: 10.1007/s12928-018-0515-z. Epub 2018 Feb 26.
• Shiode N, Kozuma K, Aoki J, Awata M, Nanasato M, Tanabe K, Yamaguchi J, Kusano H, Nie H, Kimura T; XIEVCE V/Promus PMS Investigators. The impact of coronary calcification on angiographic and 3-year clinical outcomes of everolimus-eluting stents: results of a XIENCE V/PROMUS post-marketing surveillance study. Cardiovasc Interv Ther. 2018 Oct;33(4):313-320. doi: 10.1007/s12928-017-0484-7. Epub 2017 Jul 19.
• Aoki J, Kozuma K, Awata M, Nanasato M, Shiode N, Tanabe K, Yamaguchi J, Kusano H, Nie H, Kimura T; XIEVCE V/PROMUS PMS Investigators. Three-Year Clinical Outcomes of Everolimus-Eluting Stents From the Post-Marketing Surveillance Study of Cobalt-Chromium Everolimus-Eluting Stent (XIENCE V/PROMUS) in Japan. Circ J. 2016;80(4):906-12. doi: 10.1253/circj.CJ-15-1181. Epub 2016 Jan 27.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: March 11, 2010
• First Submitted That Met QC Criteria: March 11, 2010
• First Posted (Estimate): March 15, 2010

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Stents; Angioplasty; Drug eluting stents
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases; Ischemia; Thrombosis; Coronary Occlusion; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: 09-384