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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01335659 |
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Date of registration:
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07/04/2011 |
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Primary sponsor: |
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Public title:
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Main Branch Versus Side Branch Ostial Lesion
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Scientific title:
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Relationship Between Fractional Flow Reserve and Coronary Angiography/Intravascular Ultrasound Parameters in Ostial Lesions: Major Coronary Ostial Lesions Versus Side Branch Ostial Lesions |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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77 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01335659 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Contacts
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Name:
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Bon-kwon Koo, MD/PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 21-85
- Presence of at least one obstructive coronary artery stenosis at coronary ostium as
defined by:
- Previous catheterization with any coronary ostium lesion 50% or greater
- Ability and Willingness to provide informed consent
- Ability and Willingness to perform required follow up procedures
Exclusion Criteria:
- History of coronary artery bypass graft surgery
- left main coronary ostial lesion
- significant stenosis at proximal or distal part of coronary ostium lesion
- ostial lesion related to infarcton
- Creatinine>1.6 mg/dL or GFR<30 pre-procedure per institutional standards
- Ejection fraction lower than 40%
- Known Pregnancy
- Arrhythmia
- Contrast agent allergy that cannot be adequately premedicated
- Patient not a candidate for IVUS and FFR
- Inability or unwillingness to provide informed consent
- Inability or unwillingness to perform required follow up procedures
Age minimum:
21 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Stenosis
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Intervention(s)
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Device: Fractional flow reserve
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Device: IVUS
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Primary Outcome(s)
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lumen area
[Time Frame: 1 day]
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Secondary Outcome(s)
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angiographic stenosis, % plaque area
[Time Frame: 1 day]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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