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Drug-Eluting Balloon Registry in Routine Clinical Practice

NCT ID: NCT02038660

Last Updated: 2025-12-29

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

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2027-06-30

Brief Summary

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The purpose of this study is to evaluate long-term effectiveness and safety of patients with coronary disease treated with drug eluting balloon in real world practice.

Detailed Description

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Conditions

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Coronary Artery Disease Angioplasty, Balloon

Keywords

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Coronary Artery Disease Angioplasty, Balloon

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with coronary artery disease

Balloon angioplasty

Intervention Type DEVICE

Interventions

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Balloon angioplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* After pre dilatation residual stenosis 30% and less and also without vessel dissection interrupted blood flow
* Age 20 and more
* Treated with Balloon angioplasty
* Signed informed consent and agreed to follow protocol

Exclusion Criteria

* Allergy to paclitaxel, antiplatelet
* History of side effect to heparin, aspirin, thienopyridines
* History of bleeding tendency, coagulation disorder, blood transfusion reaction
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

B. Braun Korea Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jung Park

MD,PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Soon Chun Hyang University Hospital Bucheon

Bucheon-si, , South Korea

Site Status TERMINATED

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 TERMINATED

Chonnam National University Hospital

Gwangju, , South Korea

Site Status RECRUITING

Dong-A Medical Center

Pusan, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Ulsan University Hospital

Ulsan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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CHANG-WOOK NAM, MD

Role: primary

Young Joon Hong, MD

Role: primary

MOO-HYUN KIM, MD

Role: primary

SEUNG-JUNG PARK, MD

Role: primary

Hyuck-moon Kwon, MD

Role: primary

Seung-woon Rha, MD

Role: primary

Eun Seok Shin, MD

Role: primary

Other Identifiers

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AMCCV2013-10

Identifier Type: -

Identifier Source: org_study_id