Main Branch Versus Side Branch Ostial Lesion

Completed

• Conditions: Coronary Artery Stenosis
• Interventions: Device: Fractional flow reserve; Device: IVUS

• Registration Number: NCT01335659
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Angiographic evaluation for ostial lesions is reported to be inaccurate in the assessment of the functional and clinical significance of a lesion. The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ostial lesion	Fractional flow reserve	ostial lesion will be evaluated by IVUS and FFR
ostial lesion	IVUS	ostial lesion will be evaluated by IVUS and FFR

Primary Outcome Measures

Name	Time	Method
lumen area	1 day	lumen area at ostial lesion

Secondary Outcome Measures

Name	Time	Method
angiographic stenosis, % plaque area	1 day	angiographic and intravascular ultrasound parameters at ostial lesions of each major branch and side branch.