Recruiting NCT02038660
Drug-Eluting Balloon Registry in Routine Clinical Practice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Balloon angioplasty.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Angioplasty, Balloon. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study
Overview
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.
Interventions
- Device Balloon angioplasty
Primary outcome measures
- Composite Event [Time frame: 1year]
Secondary outcome measures (10)
- All cause death [Time frame: 5year]
- Cardiac death [Time frame: 5year]
- Myocardial infarction [Time frame: 5year]
- Composite event [Time frame: 5year]
- Composite event [Time frame: 5year]
- Target vessel revascularization [Time frame: 5year]
- Target lesion revascularization [Time frame: 5year]
- Stent thrombosis [Time frame: 5year]
- Stroke [Time frame: 5year]
- Procedural Success [Time frame: 3day]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 9 centers
- Soon Chun Hyang University Hospital Bucheon — Bucheon-si
- Keimyung University Dongsan Medical Center — Daegu
- The Catholic University of Korea, Daejeon ST. Mary's Hospital — Daejeon
- Chonnam National University Hospital — Gwangju
- Dong-A Medical Center — Pusan
- Asan Medical Center — Seoul
- Gangnam Severance Hospital — Seoul
- Korea University Guro Hospital — Seoul
- … and 1 more center
Identifiers
NCT: NCT02038660 · AMCCV2013-10