Drug-Eluting Balloon Registry in Routine Clinical Practice
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorSeung-Jung Park
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Allergy to paclitaxel, antiplatelet
History of side effect to heparin, aspirin, thienopyridines
History of bleeding tendency, coagulation disorder, blood transfusion reaction
Trial population
Patients treated with balloon angioplasty
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Balloon angioplasty
Device
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: Patients with coronary artery disease1 intervention
Trial outcomes
Primary outcomes
1
Composite Event
Death, Non-fatal myocardial infarction, Target vessel revascularization
Time frame
1yearSecondary outcomes
1
All cause death
Time frame
5year2
Cardiac death
Time frame
5year3
Myocardial infarction
Time frame
5year4
Composite event
Death or myocardial infarction
Time frame
5yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seung-Jung Park
Lead sponsor
Asan Medical Center
Sponsor institution
CardioVascular Research Foundation, Korea
Collaborator
B. Braun Korea Co., Ltd.
Collaborator
Source ClinicalTrials.gov