NCT01046409UnknownNot Applicable
Comparison of Clinical, Electrical and Physiologic Significance Between Main Branch and Side Branch Vessels
Seoul National University Hospital1 site in 1 country51 target enrollmentStarted: January 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- ST elevation during 1min balloon occlusion
Study Overview
Brief Summary
The purpose of this trial is
- to compare the clinical significance of the main vessel and the side branch vessel using EKG, pain score and coronary wedge pressure
- to develop a new scoring system to predict the clinical significance of a side branch
Detailed Description
- Clinical significance EKG change, pain score during 1 min balloon occlusion
- Different characteristics between ST segment elevation vs non-elevation side branches
- Comparison of coronary wedge pressure
- Establishing a new scoring system to predict the ST elevation during 1min balloon occlusion
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
ST elevation during 1min balloon occlusion
Time Frame: Day 1 after PCI
Secondary Outcomes
- Pain score during 1min balloon occlusion(Day 1 after PCI)
- coronary wedge pressure(during the procedure)
- Usefulness of new scoring system(During the procedure)
Investigators
Bon-Kwon Koo
Associate professor
Seoul National University Hospital
Study Sites (1)
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