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Comparison Between Main Branch and Side Branch Vessels

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ClinicalTrials.gov Identifier: NCT01046409
Recruitment Status : Unknown
Verified August 2011 by Bon-Kwon Koo, Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2010
Last Update Posted : August 22, 2011
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital

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

Condition or disease Intervention/treatment
Coronary Artery Disease Other: Measuring collateral flow

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

Study Type : Observational
Estimated Enrollment : 51 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Comparison of Clinical, Electrical and Physiologic Significance Between Main Branch and Side Branch Vessels
Study Start Date : January 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Group/Cohort Intervention/treatment
Main vessel, side branch vessel Other: Measuring collateral flow
Measuring collateral flow using pressure and/or velocity coronary wire

Primary Outcome Measures :
  1. ST elevation during 1min balloon occlusion [ Time Frame: Day 1 after PCI ]

Secondary Outcome Measures :
  1. Pain score during 1min balloon occlusion [ Time Frame: Day 1 after PCI ]
  2. coronary wedge pressure [ Time Frame: during the procedure ]
  3. Usefulness of new scoring system [ Time Frame: During the procedure ]
    New scoring system includes the vessel size, myocardial territory and relationship with neighboring branches

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with significant coronary artery disease, involving the bifurcation lesions

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046409

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bon-Kwon Koo, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01046409     History of Changes
Other Study ID Numbers: H-0910-003-062
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: August 22, 2011
Last Verified: August 2011

Keywords provided by Bon-Kwon Koo, Seoul National University Hospital:
Coronary artery disease
Myocardial infarction
Myocardial ischemia

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Glucuronyl glucosamine glycan sulfate
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs