This trial is active, not recruiting.

Condition coronary artery disease
Treatment measuring collateral flow
Sponsor Seoul National University Hospital
Start date January 2010
End date December 2011
Trial size 51 participants
Trial identifier NCT01046409, H-0910-003-062


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional
measuring collateral flow
Measuring collateral flow using pressure and/or velocity coronary wire

Primary Outcomes

ST elevation during 1min balloon occlusion
time frame: Day 1 after PCI

Secondary Outcomes

Pain score during 1min balloon occlusion
time frame: Day 1 after PCI
coronary wedge pressure
time frame: during the procedure
Usefulness of new scoring system
time frame: During the procedure

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Comparison of Clinical, Electrical and Physiologic Significance Between Main Branch and Side Branch Vessels
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.