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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086228
• Other study ID #: 09-384
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: August 16, 2017
• Start date: March 2010
• Est. completion date: August 2016

Study information

• Verified date: August 2017
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2010
• Est. completion date: August 2016
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina
• Chronic Coronary Occlusion
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Occlusion
• Coronary Restenosis
• Coronary Stenosis
• Ischemia
• Myocardial Ischemia
• Stent Thrombosis
• Thrombosis
• Vascular Disease
• Vascular Diseases

Intervention

Device:
• XIENCE V / PROMUS stent
Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.

Locations

Country	Name	City	State
Japan	Site Reference ID/Investigator# 104727	Aichi
Japan	Site Reference ID/Investigator# 113428	Aichi
Japan	Site Reference ID/Investigator# 115745	Aichi
Japan	Site Reference ID/Investigator# 104424	Chiba
Japan	Site Reference ID/Investigator# 113645	Chiba
Japan	Site Reference ID/Investigator# 105015	Ehime
Japan	Site Reference ID/Investigator# 105148	Fukuoka
Japan	Site Reference ID/Investigator# 105177	Fukuoka
Japan	Site Reference ID/Investigator# 104677	Gifu
Japan	Site Reference ID/Investigator# 104365	Gunma
Japan	Site Reference ID/Investigator# 105038	Hiroshima
Japan	Site Reference ID/Investigator# 105043	Hiroshima
Japan	Site Reference ID/Investigator# 104236	Hokkaido
Japan	Site Reference ID/Investigator# 105963	Hyogo
Japan	Site Reference ID/Investigator# 104326	Ibaraki
Japan	Site Reference ID/Investigator# 104606	Ishikawa
Japan	Site Reference ID/Investigator# 104607	Ishikawa
Japan	Site Reference ID/Investigator# 104528	Kanagawa
Japan	Site Reference ID/Investigator# 104536	Kanagawa
Japan	Site Reference ID/Investigator#104563	Kanagawa
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	Kyoto
Japan	Site Reference ID/Investigator# 104658	Nagano
Japan	Site Reference ID/Investigator# 104990	Nara
Japan	Site Reference ID/Investigator# 105027	Okayama
Japan	Site Reference ID/Investigator# 105296	Okinawa
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	Osaka
Japan	Site Reference ID/Investigator# 104407	Saitama
Japan	Site Reference ID/Investigator# 106044	Saitama
Japan	Site Reference ID/Investigator# 104697	Shizuoka
Japan	Site Reference ID/Investigator# 104356	Tochigi
Japan	Site Reference ID/Investigator# 105092	Tokushima
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	Tokyo
Japan	Site Reference ID/Investigator # 104285	Yamagata
Japan	Site Reference ID/Investigator# 104294	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Number of Participants With Adverse Events Related to Anti-platelet Medication		From post-procedure to 1 year
Secondary	Number of Participants With Adverse Events Related to Anti-platelet Medication		From 1 year to 2 years
Secondary	Number of Participants With Adverse Events Related to Anti-platelet Medication		From 2 years to 3 years
Secondary	Number of Participants With Adverse Events Related to Anti-platelet Medication		From 3 years to 4 years
Secondary	Number of Participants With Adverse Events Related to Anti-platelet Medication		From 4 years to 5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Acute Gain	The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).	On day 0 after procedure
Secondary	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
Secondary	Net Gain	Net Gain = Acute Gain - Late Loss, paired analysis only.	On day 0 after procedure
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)		Post Procedure to 1 Year
Secondary	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)		From 1 Year to 2 Years
Secondary	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)		From 2 Years to 3 Years
Secondary	Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR		Post Procedure to 1 Year
Secondary	Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR		From 1 Year to 2 Years
Secondary	Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR		From 2 Years to 3 Years
Secondary	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)		Post Procedure to 1 Year
Secondary	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)		From 1 Year to 2 Years
Secondary	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)		From 2 Years to 3 Years
Secondary	Number of Participants With All Deaths and All MI		Post Procedure to 1 Year
Secondary	Number of Participants With All Deaths and All MI		From 1 Year to 2 Years
Secondary	Number of Participants With All Deaths and All MI		From 2 Years to 3 Years
Secondary	Number of Participants With All Deaths, All MI and All Revascularization		Post Procedure to 1 Year
Secondary	Number of Participants With All Deaths, All MI and All Revascularization		From 1 Year to 2 Years
Secondary	Number of Participants With All Deaths, All MI and All Revascularization		From 2 Years to 3 Years
Secondary	Number of Participants With All Deaths, TVMI and TLR		Post Procedure to 1 Year
Secondary	Number of Participants With All Deaths, TVMI and TLR		From 1 Year to 2 Years
Secondary	Number of Participants With All Deaths, TVMI and TLR		From 2 Years to 3 Years
Secondary	Number of Participants With All Deaths, TVMI and CI-TLR		Post Procedure to 1 Year
Secondary	Number of Participants With All Deaths, TVMI and CI-TLR		From 1 Year to 2 Years
Secondary	Number of Participants With All Deaths, TVMI and CI-TLR		From 2 Years to 3 Years