Clinical trial NCT01086228: XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
Official title: XIENCE V/PROMUS Everolimus-Eluting Stent System Japan Post-marketing Surveillance Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angina
Chronic Coronary Occlusion
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Keywords: Drug eluting stents
Stents
Angioplasty
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 2010
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.

Primary outcomes:
measure: Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
timeFrame: From 1 Year to 2 Years
measure: Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
timeFrame: From 2 years to 3 years
Secondary outcomes:
measure: Number of Participants With Adverse Events Related to Anti-platelet Medication
timeFrame: From post-procedure to 1 year
measure: Number of Participants With Adverse Events Related to Anti-platelet Medication
timeFrame: From 1 year to 2 years
measure: Number of Participants With Adverse Events Related to Anti-platelet Medication
timeFrame: From 2 years to 3 years
measure: Number of Participants With Adverse Events Related to Anti-platelet Medication
timeFrame: From 3 years to 4 years
measure: Number of Participants With Adverse Events Related to Anti-platelet Medication
timeFrame: From 4 years to 5 years
measure: Percent Diameter Stenosis (%DS)
timeFrame: Baseline
measure: Percent Diameter Stenosis (%DS)
timeFrame: On day 0 after procedure
measure: Percent Diameter Stenosis (%DS)
timeFrame: At 8 months
measure: Acute Gain
timeFrame: On day 0 after procedure
measure: Late Loss
timeFrame: On day 0 after procedure
measure: Net Gain
timeFrame: On day 0 after procedure
measure: Acute Success
timeFrame: On day 0 (Immediately post-index procedure)
measure: Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
timeFrame: From 1 to 2 years
measure: Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
timeFrame: From 2 years to 3 years
measure: Number of Participants With Myocardial Infarctions (MI)
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With Myocardial Infarctions (MI)
timeFrame: From 1 year to 2 years
measure: Number of Participants With Myocardial Infarctions (MI)
timeFrame: From 2 years to 3 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: From 1 year to 2 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: From 2 years to 3 years
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: From 1 Year to 2 Years
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: From 2 Years to 3 Years
measure: Number of Participants With Cardiac Death and All MI
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With Cardiac Death and All MI
timeFrame: From 1 Year to 2 Years
measure: Number of Participants With Cardiac Death and All MI
timeFrame: From 2 Years to 3 Years
measure: Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
timeFrame: From 1 Year to 2 Years
measure: Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
timeFrame: From 2 Years to 3 Years
measure: Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
timeFrame: From 1 Year to 2 Years
measure: Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
timeFrame: From 2 Years to 3 Years
measure: Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
timeFrame: From 1 Year to 2 Years
measure: Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
timeFrame: From 2 Years to 3 Years
measure: Number of Participants With All Deaths and All MI
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With All Deaths and All MI
timeFrame: From 1 Year to 2 Years
measure: Number of Participants With All Deaths and All MI
timeFrame: From 2 Years to 3 Years
measure: Number of Participants With All Deaths, All MI and All Revascularization
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With All Deaths, All MI and All Revascularization
timeFrame: From 1 Year to 2 Years
measure: Number of Participants With All Deaths, All MI and All Revascularization
timeFrame: From 2 Years to 3 Years
measure: Number of Participants With All Deaths, TVMI and TLR
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With All Deaths, TVMI and TLR
timeFrame: From 1 Year to 2 Years
measure: Number of Participants With All Deaths, TVMI and TLR
timeFrame: From 2 Years to 3 Years
measure: Number of Participants With All Deaths, TVMI and CI-TLR
timeFrame: Post Procedure to 1 Year
measure: Number of Participants With All Deaths, TVMI and CI-TLR
timeFrame: From 1 Year to 2 Years
measure: Number of Participants With All Deaths, TVMI and CI-TLR
timeFrame: From 2 Years to 3 Years
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 104727
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 113428
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 115745
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 104424
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 113645
city: Ehime
country: Japan
facility: Site Reference ID/Investigator# 105015
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 105148
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 105177
city: Gifu
country: Japan
facility: Site Reference ID/Investigator# 104677
city: Gunma
country: Japan
facility: Site Reference ID/Investigator# 104365
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 105038
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 105043
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 104236
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 105963
city: Ibaraki
country: Japan
facility: Site Reference ID/Investigator# 104326
city: Ishikawa
country: Japan
facility: Site Reference ID/Investigator# 104606
city: Ishikawa
country: Japan
facility: Site Reference ID/Investigator# 104607
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 104528
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 104536
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator#104563
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 104837
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 104838
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 104843
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 104844
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 104850
city: Nagano
country: Japan
facility: Site Reference ID/Investigator# 104658
city: Nara
country: Japan
facility: Site Reference ID/Investigator# 104990
city: Okayama
country: Japan
facility: Site Reference ID/Investigator# 105027
city: Okinawa
country: Japan
facility: Site Reference ID/Investigator# 105296
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 104864
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 104898
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 104906
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 114863
city: Saitama
country: Japan
facility: Site Reference ID/Investigator# 104407
city: Saitama
country: Japan
facility: Site Reference ID/Investigator# 106044
city: Shizuoka
country: Japan
facility: Site Reference ID/Investigator# 104697
city: Tochigi
country: Japan
facility: Site Reference ID/Investigator# 104356
city: Tokushima
country: Japan
facility: Site Reference ID/Investigator# 105092
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 104448
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 104454
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 104473
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 104497
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 104510
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 104514
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator#104481
city: Yamagata
country: Japan
facility: Site Reference ID/Investigator # 104285
city: Yamagata
country: Japan
facility: Site Reference ID/Investigator# 104294
Study officials:
affiliation: Abbott Medical Devices
name: Gary Thompson
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.