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

NCT ID: NCT01086228

Last Updated: 2018-02-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2010 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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XIENCE V / PROMUS stent

Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.

XIENCE V / PROMUS stent

Intervention Type DEVICE

Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.

Interventions

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XIENCE V / PROMUS stent

Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary Thompson

Role: STUDY_DIRECTOR

Abbott Medical Devices

Locations

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Site Reference ID/Investigator# 104727

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 113428

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 115745

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 104424

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 113645

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 105015

Ehime, , Japan

Site Status

Site Reference ID/Investigator# 105148

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 105177

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 104677

Gifu, , Japan

Site Status

Site Reference ID/Investigator# 104365

Gunma, , Japan

Site Status

Site Reference ID/Investigator# 105038

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 105043

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 104236

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 105963

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 104326

Ibaraki, , Japan

Site Status

Site Reference ID/Investigator# 104606

Ishikawa, , Japan

Site Status

Site Reference ID/Investigator# 104607

Ishikawa, , Japan

Site Status

Site Reference ID/Investigator# 104528

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 104536

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator#104563

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 104837

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 104838

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 104843

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 104844

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 104850

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 104658

Nagano, , Japan

Site Status

Site Reference ID/Investigator# 104990

Nara, , Japan

Site Status

Site Reference ID/Investigator# 105027

Okayama, , Japan

Site Status

Site Reference ID/Investigator# 105296

Okinawa, , Japan

Site Status

Site Reference ID/Investigator# 104864

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 104898

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 104906

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 114863

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 104407

Saitama, , Japan

Site Status

Site Reference ID/Investigator# 106044

Saitama, , Japan

Site Status

Site Reference ID/Investigator# 104697

Shizuoka, , Japan

Site Status

Site Reference ID/Investigator# 104356

Tochigi, , Japan

Site Status

Site Reference ID/Investigator# 105092

Tokushima, , Japan

Site Status

Site Reference ID/Investigator# 104448

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 104454

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 104473

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 104497

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 104510

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 104514

Tokyo, , Japan

Site Status

Site Reference ID/Investigator#104481

Tokyo, , Japan

Site Status

Site Reference ID/Investigator # 104285

Yamagata, , Japan

Site Status

Site Reference ID/Investigator# 104294

Yamagata, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 29484580 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28726115 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26821583 (View on PubMed)

Other Identifiers

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09-384

Identifier Type: -

Identifier Source: org_study_id

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