AnginaNCT01086228
XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
An observational study of Angina and Chronic Coronary Occlusion, run by Abbott Medical Devices at 47 sites in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angina, Chronic Coronary Occlusion, Stent Thrombosis
- What is being tested?
- XIENCE V / PROMUS stent
- Type of treatment
- Medical device
- How many people
- 2,010 participants
- Where
- 47 sitesJapan
- Study dates
- Mar 2010to Aug 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Only XIENCE V stent(s)or PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
Who cannot join
- Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
Site Reference ID/Investigator# 104727
Aichi
Site Reference ID/Investigator# 113428
Aichi
Site Reference ID/Investigator# 115745
Aichi
Site Reference ID/Investigator# 104424
Chiba
Site Reference ID/Investigator# 113645
Chiba
Site Reference ID/Investigator# 105015
Ehime
Site Reference ID/Investigator# 105148
Fukuoka
Site Reference ID/Investigator# 105177
Fukuoka
Site Reference ID/Investigator# 104677
Gifu
Site Reference ID/Investigator# 104365
Gunma
Site Reference ID/Investigator# 105038
Hiroshima
Site Reference ID/Investigator# 105043
Hiroshima
Site Reference ID/Investigator# 104236
Hokkaido
Site Reference ID/Investigator# 105963
Hyōgo
Site Reference ID/Investigator# 104326
Ibaraki
Site Reference ID/Investigator# 104606
Ishikawa
Site Reference ID/Investigator# 104607
Ishikawa
Site Reference ID/Investigator# 104528
Kanagawa
Site Reference ID/Investigator# 104536
Kanagawa
Site Reference ID/Investigator#104563
Kanagawa
Site Reference ID/Investigator# 104837
Kyoto
Site Reference ID/Investigator# 104838
Kyoto
Site Reference ID/Investigator# 104843
Kyoto
Site Reference ID/Investigator# 104844
Kyoto
Site Reference ID/Investigator# 104850
Kyoto
Site Reference ID/Investigator# 104658
Nagano
Site Reference ID/Investigator# 104990
Nara
Site Reference ID/Investigator# 105027
Okayama
Site Reference ID/Investigator# 105296
Okinawa
Site Reference ID/Investigator# 104864
Osaka
Site Reference ID/Investigator# 104898
Osaka
Site Reference ID/Investigator# 104906
Osaka
Site Reference ID/Investigator# 114863
Osaka
Site Reference ID/Investigator# 104407
Saitama
Site Reference ID/Investigator# 106044
Saitama
Site Reference ID/Investigator# 104697
Shizuoka
Site Reference ID/Investigator# 104356
Tochigi
Site Reference ID/Investigator# 105092
Tokushima
Site Reference ID/Investigator# 104448
Tokyo
Site Reference ID/Investigator# 104454
Tokyo
Site Reference ID/Investigator# 104473
Tokyo
Site Reference ID/Investigator# 104497
Tokyo
Site Reference ID/Investigator# 104510
Tokyo
Site Reference ID/Investigator# 104514
Tokyo
Site Reference ID/Investigator#104481
Tokyo
Site Reference ID/Investigator # 104285
Yamagata
Site Reference ID/Investigator# 104294
Yamagata
About this study
Official title: 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.
Read the 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.
- Conditions
- Angina, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Being tested
- XIENCE V / PROMUS stent
- Keywords
- Drug eluting stents, Stents, Angioplasty
- Medical subject headings
- Angina Pectoris, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE V / PROMUS stentDevice
Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
| Study group | Role | What they receive |
|---|---|---|
| XIENCE V / PROMUS stent | Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. Receives: Device: XIENCE V / PROMUS stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: From 2 years to 3 years
Secondary outcomes (48)
Number of Participants With Adverse Events Related to Anti-platelet Medication
Measured: From post-procedure to 1 year
Number of Participants With Adverse Events Related to Anti-platelet Medication
Measured: From 1 year to 2 years
Number of Participants With Adverse Events Related to Anti-platelet Medication
Measured: From 2 years to 3 years
Number of Participants With Adverse Events Related to Anti-platelet Medication
Measured: From 3 years to 4 years
Number of Participants With Adverse Events Related to Anti-platelet Medication
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At 8 months
Acute Gain
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Measured: 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].
Measured: On day 0 after procedure
Net Gain
Net Gain = Acute Gain - Late Loss, paired analysis only.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 2 Years to 3 Years
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Measured: Post Procedure to 1 Year
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Measured: From 1 Year to 2 Years
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Measured: From 2 Years to 3 Years
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Measured: Post Procedure to 1 Year
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Measured: From 1 Year to 2 Years
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Measured: From 2 Years to 3 Years
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Measured: Post Procedure to 1 Year
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Measured: From 1 Year to 2 Years
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Measured: From 2 Years to 3 Years
Number of Participants With All Deaths and All MI
Measured: Post Procedure to 1 Year
Number of Participants With All Deaths and All MI
Measured: From 1 Year to 2 Years
Number of Participants With All Deaths and All MI
Measured: From 2 Years to 3 Years
Number of Participants With All Deaths, All MI and All Revascularization
Measured: Post Procedure to 1 Year
Number of Participants With All Deaths, All MI and All Revascularization
Measured: From 1 Year to 2 Years
Number of Participants With All Deaths, All MI and All Revascularization
Measured: From 2 Years to 3 Years
Number of Participants With All Deaths, TVMI and TLR
Measured: Post Procedure to 1 Year
Number of Participants With All Deaths, TVMI and TLR
Measured: From 1 Year to 2 Years
Number of Participants With All Deaths, TVMI and TLR
Measured: From 2 Years to 3 Years
Number of Participants With All Deaths, TVMI and CI-TLR
Measured: Post Procedure to 1 Year
Number of Participants With All Deaths, TVMI and CI-TLR
Measured: From 1 Year to 2 Years
Number of Participants With All Deaths, TVMI and CI-TLR
Measured: From 2 Years to 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2012
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnginaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Thompson, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086228
- Sponsor's protocol ID
- 09-384
- Status last verified
- Aug 2017
- First submitted
- 11 Mar 2010
- Last updated
- 19 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 29484580Shiode 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.
PubMed 28726115Aoki 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.
PubMed 26821583
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XIENCE V/PROMUS Everolimus-Eluting Stent System Japan Post-marketing Surveillance Protocol
- ClinicalTrials.gov ID
- NCT01086228
- Acronym / sponsor ID
- 09-384
- Conditions
- Angina, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Keywords
- Drug eluting stents, Stents, Angioplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,010 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Mar 2010 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XIENCE V / PROMUS stent | – | Device: XIENCE V / PROMUS stentOnly the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Only XIENCE V stent(s)or PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
Key exclusion criteria (1 listed)
- Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XIENCE V / PROMUS stentPatients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure. | Device | XIENCE V / PROMUS stent |
Primary outcome
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
48 secondary outcomes
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 (%DS)
Time frame: On day 0 after procedure
Percent Diameter Stenosis (%DS)
Time frame: At 8 months
Acute Gain
Time frame: On day 0 after procedure
Late Loss
Time frame: On day 0 after procedure
Net Gain
Time frame: On day 0 after procedure
Acute Success
Time frame: On day 0 (Immediately post-index procedure)
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
Time frame: Post Procedure to 1 Year
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
Time frame: From 1 to 2 years
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
Time frame: From 2 years to 3 years
Number of Participants With Myocardial Infarctions (MI)
Time frame: Post Procedure to 1 Year
Number of Participants With Myocardial Infarctions (MI)
Time frame: From 1 year to 2 years
Number of Participants With Myocardial Infarctions (MI)
Time frame: From 2 years to 3 years
Number of Participants With Target Lesion Revascularization (TLR)
Time frame: Post Procedure to 1 Year
Number of Participants With Target Lesion Revascularization (TLR)
Time frame: From 1 year to 2 years
Number of Participants With Target Lesion Revascularization (TLR)
Time frame: From 2 years to 3 years
Number of Participants With Target Vessel Revascularization (TVR)
Time frame: Post Procedure to 1 Year
Number of Participants With Target Vessel Revascularization (TVR)
Time frame: From 1 Year to 2 Years
Number of Participants With Target Vessel Revascularization (TVR)
Time frame: From 2 Years to 3 Years
Number of Participants With Cardiac Death and All MI
Time frame: Post Procedure to 1 Year
Number of Participants With Cardiac Death and All MI
Time frame: From 1 Year to 2 Years
Number of Participants With Cardiac Death and All MI
Time frame: From 2 Years to 3 Years
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29484580Aoki 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.
- Derived from this study: PubMed 28726115Shiode 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.
- Derived from this study: PubMed 26821583Aoki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Thompson study director
Abbott Medical Devices
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina and Chronic Coronary Occlusion, run by Abbott Medical Devices at 47 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition (time frame: Post Procedure to 1 Year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01086228, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.