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Comparison Between Main Branch and Side Branch Vessels

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Bon-Kwon Koo, Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01046409
First Posted: January 12, 2010
Last Update Posted: August 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital
January 8, 2010
January 12, 2010
August 22, 2011
January 2010
December 2011   (Final data collection date for primary outcome measure)
ST elevation during 1min balloon occlusion [ Time Frame: Day 1 after PCI ]
Collateral flow index of main vessel and side branch vessel [ Time Frame: Day 1 after PCI ]
Complete list of historical versions of study NCT01046409 on ClinicalTrials.gov Archive Site
  • 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 ]
    New scoring system includes the vessel size, myocardial territory and relationship with neighboring branches
Pw/Pa of main vessel and side branch vessel [ Time Frame: Day 1 after PCI ]
Not Provided
Not Provided
 
Comparison Between Main Branch and Side Branch Vessels
Comparison of Clinical, Electrical and Physiologic Significance Between Main Branch and Side Branch Vessels

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
  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
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
Patients with significant coronary artery disease, involving the bifurcation lesions
Coronary Artery Disease
Other: Measuring collateral flow
Measuring collateral flow using pressure and/or velocity coronary wire
Main vessel, side branch vessel
Intervention: Other: Measuring collateral flow

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
51
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01046409
H-0910-003-062
No
Not Provided
Not Provided
Bon-Kwon Koo, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
August 2011