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Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent in Routine Clinical Practice

NCT ID: NCT04443530

Last Updated: 2024-12-24

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

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-17

Study Completion Date

2030-12-31

Brief Summary

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This study is to evaluate the effectiveness and safety of Ultimaster Tansei stent in the "real-world" daily practice.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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Tansei Ultimaster Ultimaster Tansei

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary artery stenosis

Patients with coronary artery disease

Ultimaster™ Tansei™ stents

Intervention Type DRUG

Patients receiving Ultimaster™ Tansei™ stents

Interventions

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Ultimaster™ Tansei™ stents

Patients receiving Ultimaster™ Tansei™ stents

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients ≥ 19 years old
2. Patients receiving Ultimaster™ Tansei™ stents.
3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria

1. Patients with a mixture of other drug-eluting stents (DESs)
2. Terminal illness with life-expectancy ≤1 year.
3. Patients with cardiogenic shock
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Duk-Woo Park, MD

OTHER

Sponsor Role lead

Responsible Party

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Duk-Woo Park, MD

Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Gangwon National Univ. Hospital

Chuncheon, , South Korea

Site Status RECRUITING

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status RECRUITING

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status RECRUITING

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, , South Korea

Site Status RECRUITING

Gangneung Asan Hospital

Gangneung, , South Korea

Site Status RECRUITING

Kwangju Christian Hospital

Kwangju, , South Korea

Site Status RECRUITING

Pusan National University Hospital

Pusan, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Kangdong Sacred Heart Hospital

Seoul, , South Korea

Site Status RECRUITING

The Catholic Univ. of Korea Eunpyeong St. Mary's hospital

Seoul, , South Korea

Site Status WITHDRAWN

St.Carollo Hospital

Suncheon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung-hee Ham, RN

Role: CONTACT

Phone: 82230104728

Email: [email protected]

Facility Contacts

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Bong-ki Lee, MD

Role: primary

Jin-bae Lee, MD

Role: primary

Hyuck-joon Yoon, MD

Role: primary

Man-won Park, MD

Role: primary

Han-bit Park, MD

Role: primary

Seung-uk Lee, MD

Role: primary

Han-cheol Lee, MD

Role: primary

Duk-woo Park, MD

Role: primary

Won-woo Seo, MD

Role: primary

Jang-hyun Cho, MD

Role: primary

Other Identifiers

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AMCCV2020-07

Identifier Type: -

Identifier Source: org_study_id