Effect and Efficacy of Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerosis

NCT ID: NCT02845804

Last Updated: 2016-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1533 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2021-07-31

Brief Summary

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The objectives of this study are

1. To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent
2. To evaulate the long-term efficacy and safety of coronary stenting with the Xience Xpedition™/Alpine™ stent
3. To compare the long-term efficacy and safety of coronary stenting between the Xience Xpedition™/Alpine ™ stent and other contemporary drug-eluting stents which had established their own registry

Detailed Description

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Secondary endpoints of this study are

Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI

Target vessl failure

Composite rate of cardiac death and any MI, 3 years

Composite rate of all death and any MI

Composite rate of all death, any MI, and any repeat revascularization

Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy

Conditions

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Coronary Artery Disease Percutaneous Coronary Intervention Acute Coronary Syndrome Angina Pectoris

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Alpine

The patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™

Alpine

Intervention Type DEVICE

Interventions

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Alpine

Intervention Type DEVICE

Other Intervention Names

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Everolimus-eluting stent

Eligibility Criteria

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Inclusion Criteria

* The patient agrees to participate in this study by signing the informed consent form.

Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyo-soo Kim, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

Site Status RECRUITING

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status RECRUITING

Sejong General Hospital

Bucheon-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status RECRUITING

Busan Paik Hospital

Busan, , South Korea

Site Status RECRUITING

Kosin University Gospel Hospital

Busan, , South Korea

Site Status RECRUITING

Dankook University Hospital

Cheonan, , South Korea

Site Status RECRUITING

SoonChunHyang University Cheonan Hospital

Cheonan, , South Korea

Site Status RECRUITING

Yongnam University Medical Center

Daegu, , South Korea

Site Status RECRUITING

Chonnam National University Hospital

Gwangju, , South Korea

Site Status RECRUITING

Wonkwang University Hospital

Iksan, , South Korea

Site Status RECRUITING

Inha University Hospital

Inchon, , South Korea

Site Status RECRUITING

Chungbuk National University Hospital

Jeonju, , South Korea

Site Status RECRUITING

Presbyterian Medical Center

Jeonju, , South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status RECRUITING

Gangbuk Samsung Hospital

Seoul, , South Korea

Site Status RECRUITING

Hanyang University Medical Center

Seoul, , South Korea

Site Status RECRUITING

Kangdong Sacred Heart Hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul Boramae Hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyo-soo Kim, MD, PhD

Role: CONTACT

+82-2-2072-2226

Facility Contacts

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Yong-Hoon Kim

Role: primary

Jung-Han Yoon

Role: primary

Young-Jin Choi

Role: primary

Sang-Ho Jo, MD,PhD

Role: primary

Tae-Hyun Yang

Role: primary

Jeong Ho Heo

Role: primary

Byung-Eun Park, MD,PhD

Role: primary

Sang-Ho Park

Role: primary

Jong-Sun Park, MD,PhD

Role: primary

Myung-Ho Jeong

Role: primary

Seok-Kyo Oh, MD,PhD

Role: primary

Seong-Il Woo, MD,PhD

Role: primary

Jang-Hwan Bae, MD,PhD

Role: primary

Je-Young Rhew, MD,PhD

Role: primary

In-Ho Chae, MD,PhD

Role: primary

Ki-Cheol Sung, MD,PhD

Role: primary

Young-Hyo Lim

Role: primary

Kyoo-Rok Han, MD,PhD

Role: primary

Sang-Hyun Kim, MD,PhD

Role: primary

Hyo-soo Kim, MD, PhD

Role: primary

+82-2-2072-2223

Other Identifiers

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HOST-ALPINE

Identifier Type: -

Identifier Source: org_study_id

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