Drug-Eluting Balloon Registry in Routine Clinical Practice | NCT02038660

Studies
Drug-Eluting Balloon Registry in Routine Clinical Practice

NCT02038660

Sponsor

Seung-Jung Park

Status

Recruiting

Last Update Posted

Dec 29, 2025Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Coronary Artery Disease
Angioplasty, Balloon

Interventions

Balloon angioplasty

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Jan 15, 2014

First Submission Date that Met QC Criteria

Jan 15, 2014

First Posted Date

Jan 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2025

Last Update Posted Date

Dec 29, 2025Actual

Name	Class
CardioVascular Research Foundation, Korea	OTHER
B. Braun Korea Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Label	Type	Description	Intervention Names
Patients with coronary artery disease			Device: Balloon angioplasty

Name	Type	Description	Arm Group Labels	Other Names
Balloon angioplasty	Device		Patients with coronary artery disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite Event	Death, Non-fatal myocardial infarction, Target vessel revascularization	1year

Secondary Outcomes

Measure	Description	Time Frame
All cause death		5year
Cardiac death		5year
Myocardial infarction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients treated with balloon angioplasty

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soon Chun Hyang University Hospital Bucheon	Terminated	Bucheon-si			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

This is not a publicly funded trial.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000800	Angioplasty, Balloon

Ancestor Terms

ID	Term
D017130	Angioplasty
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures

Browse Leaves

Not provided

Browse Branches

Not provided