Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, Bifurcation, Myocardial infarction, Myocardial ischemia, Collateral
Brief summary
The purpose of this trial is 1. to compare the clinical significance of the main vessel and the side branch vessel using EKG, pain score and coronary wedge pressure 2. to develop a new scoring system to predict the clinical significance of a side branch
Detailed description
1. Clinical significance EKG change, pain score during 1 min balloon occlusion 2. Different characteristics between ST segment elevation vs non-elevation side branches 3. Comparison of coronary wedge pressure 4. Establishing a new scoring system to predict the ST elevation during 1min balloon occlusion
Interventions
OTHERMeasuring collateral flow
Measuring collateral flow using pressure and/or velocity coronary wire
Sponsors
Seoul National University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Able to verbally confirm understandings of risks, benefits of receiving percutaneous coronary intervention (PCI) for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure * Significant stenosis at bifurcation lesion (\>50% by visual estimate) which always includes stenosis of side branch (true bifurcation) * Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) in a native coronary artery with diameter of ≥ 2.25 mm * Target lesion(s) amenable for PCI with final kissing balloon angioplasty for the side branch
Exclusion criteria
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment) * Patients refuse to give informed consent * Patients with left main coronary artery stenosis * Patients with total occlusion of the bifurcation lesion * Patients with infarct-related artery at the lesion of interest * Patients with left ventricular ejection fraction\<40% * Patients with primary cardiomyopathy * Patients with chronic kidney disease defined as serum Cr\>2.0 * Patients who have severe side effects or contraindication to adenosine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ST elevation during 1min balloon occlusion | Day 1 after PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score during 1min balloon occlusion | Day 1 after PCI | — |
| coronary wedge pressure | during the procedure | — |
| Usefulness of new scoring system | During the procedure | New scoring system includes the vessel size, myocardial territory and relationship with neighboring branches |
Countries
South Korea
Outcome results
None listed