Drug-Eluting Balloon Registry in Routine Clinical Practice

NCT02038660 | Recruiting DMC

• 1 other identifier: AMCCV2013-10
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 9

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.

Conditions

Coronary Artery Disease; Angioplasty, Balloon

Keywords

Coronary Artery Disease; Angioplasty, Balloon

Outcome Measures

Primary Outcomes (1)

• Composite Event

  Death, Non-fatal myocardial infarction, Target vessel revascularization

  1year

Secondary Outcomes (10)

• All cause death

  5year

• Cardiac death

  5year

• Myocardial infarction

  5year

• Composite event

  5year

• Composite event

  5year

Study Arms (1)

Patients with coronary artery disease

Device: Balloon angioplasty

Interventions

Balloon angioplasty DEVICE

Patients with coronary artery disease

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with balloon angioplasty

You may qualify if:

• 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

You may not qualify if:

• Allergy to paclitaxel, antiplatelet
• History of side effect to heparin, aspirin, thienopyridines
• History of bleeding tendency, coagulation disorder, blood transfusion reaction

Sponsors & Collaborators

• CardioVascular Research Foundation, Korea: collaborator
• Seung-Jung Park: lead
• B. Braun Korea Co., Ltd.: collaborator

Study Sites (9)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

TERMINATED

Keimyung University Dongsan Medical Center

Daegu, South Korea

RECRUITING

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

Daejeon, South Korea

TERMINATED

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Dong-A Medical Center

Pusan, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

NOT YET RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 16, 2014
• Study Start: January 1, 2014
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (9)