Main Branch Versus Side Branch Ostial Lesion

NCT01335659 | Completed

• 1 other identifier: Bif_3
• Study Type: observational
• Target: 77
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.

Conditions

Coronary Artery Stenosis

Keywords

FFR; IVUS; QCA

Outcome Measures

Primary Outcomes (1)

• lumen area

  lumen area at ostial lesion

  1 day

Secondary Outcomes (1)

• angiographic stenosis, % plaque area

  1 day

Study Arms (1)

ostial lesion

ostial lesion will be evaluated by IVUS and FFR

Device: Fractional flow reserve; Device: IVUS

Interventions

Fractional flow reserve DEVICE

Fractional flow reserve measured by pressure wire

Also known as: Radi Pressure Wire(Radi Medical Systems, Uppsala, Sweden)

ostial lesion

IVUS DEVICE

intravascular ultrasound :IVUS was performed in a standard fashion using an automated motorized pullback system (0.5mm/s) with commercially available imaging catheter

Also known as: iLab® Ultrasound Imaging System(Boston Scientific/SCIMED, Minneapolis, MN, USA)

ostial lesion

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

from september 2009 to january 2011 patient who are undergone coronary angiography,IVUS and FFR for the evaluation of coronary artery disease at SNUH

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Related Publications (1)

• Koh JS, Koo BK, Kim JH, Yang HM, Park KW, Kang HJ, Kim HS, Oh BH, Park YB. Relationship between fractional flow reserve and angiographic and intravascular ultrasound parameters in ostial lesions: major epicardial vessel versus side branch ostial lesions. JACC Cardiovasc Interv. 2012 Apr;5(4):409-15. doi: 10.1016/j.jcin.2012.01.013.

  PMID: 22516397 DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Bon-kwon Koo, MD/PhD

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 14, 2011
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2011-07