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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02038660
Other study ID # AMCCV2013-10
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2014
Est. completion date June 2028

Study information

Verified date December 2023
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date June 2028
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Device:
Balloon angioplasty


Locations

Country Name City State
Korea, Republic of Soon Chun Hyang University Hospital Bucheon Bucheon
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of The Catholic University of Korea, Daejeon ST. Mary's Hospital Daejeon
Korea, Republic of Dong-A Medical Center Pusan
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Ulsan University Hospital Ulsan

Sponsors (3)

Lead Sponsor Collaborator
Seung-Jung Park B. Braun Korea Co., Ltd., CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite Event Death, Non-fatal myocardial infarction, Target vessel revascularization 1year
Secondary All cause death 5year
Secondary Cardiac death 5year
Secondary Myocardial infarction 5year
Secondary Composite event Death or myocardial infarction 5year
Secondary Composite event Cardiac death or myocardial infarction 5year
Secondary Target vessel revascularization 5year
Secondary Target lesion revascularization 5year
Secondary Stent thrombosis Classification of stent thrombosis according to Academic Research Consortium criteria 5year
Secondary Stroke 5year
Secondary Procedural Success Defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization.
Participants will be followed for the duration of hospital stay, an expected average of 3days.
3day
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