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Clinical Trials/NCT02038660
NCT02038660
Recruiting
Not Applicable

Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study

Seung-Jung Park9 sites in 1 country1,500 target enrollmentJanuary 1, 2014
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ConditionsCoronary Artery DiseaseAngioplasty, Balloon

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Seung-Jung Park
Enrollment
1500
Locations
9
Primary Endpoint
Composite Event
Status
Recruiting
Last Updated
4 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
June 1, 2027
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Seung-Jung Park
Responsible Party
Sponsor Investigator
Principal Investigator

Seung-Jung Park

MD,PhD

Asan Medical Center

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

Outcomes

Primary Outcomes

Composite Event

Time Frame: 1year

Death, Non-fatal myocardial infarction, Target vessel revascularization

Secondary Outcomes

  • All cause death(5year)
  • Myocardial infarction(5year)
  • Composite event(5year)
  • Target vessel revascularization(5year)
  • Target lesion revascularization(5year)
  • Stent thrombosis(5year)
  • Stroke(5year)
  • Cardiac death(5year)
  • Procedural Success(3day)

Study Sites (9)

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