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Comparison Between Main Branch and Side Branch Vessels

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Seoul National University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01046409
First received: January 8, 2010
Last updated: August 18, 2011
Last verified: August 2011

January 8, 2010
August 18, 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 ] [ Designated as safety issue: No ]
Collateral flow index of main vessel and side branch vessel [ Time Frame: Day 1 after PCI ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • coronary wedge pressure [ Time Frame: during the procedure ] [ Designated as safety issue: No ]
  • Usefulness of new scoring system [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
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.
 
Active, not recruiting
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01046409
H-0910-003-062
No
Bon-Kwon Koo, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP