Drug-Eluting Balloon Registry in Routine Clinical Practice

Recruiting

• Conditions: Angioplasty, Balloon; Coronary Artery Disease
• Interventions: Device: Balloon angioplasty

• Registration Number: NCT02038660
• Lead Sponsor: Seung-Jung Park

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-16
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-20
• Primary Completion: 2024-12-31
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with coronary artery disease	Balloon angioplasty	-

Primary Outcome Measures

Name	Time	Method
Composite Event	1year	Death, Non-fatal myocardial infarction, Target vessel revascularization

Secondary Outcome Measures

Name	Time	Method
All cause death	5year
Myocardial infarction	5year
Composite event	5year	Cardiac death or myocardial infarction
Target vessel revascularization	5year
Target lesion revascularization	5year
Stent thrombosis	5year	Classification of stent thrombosis according to Academic Research Consortium criteria
Stroke	5year
Cardiac death	5year
Procedural Success	3day	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.

Trial Locations

Locations (8)

The Catholic University of Korea, Daejeon ST. Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Dong-A Medical Center; 🇰🇷 Pusan, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, 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