Main Branch Versus Side Branch Ostial Lesion

NCT ID: NCT01335659

Last Updated: 2011-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-06-30

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.

Conditions

Coronary Artery Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

ostial lesion

ostial lesion will be evaluated by IVUS and FFR

Fractional flow reserve

Intervention Type: DEVICE

Fractional flow reserve measured by pressure wire

IVUS

Intervention Type: DEVICE

intravascular ultrasound

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

Interventions

Fractional flow reserve

Fractional flow reserve measured by pressure wire

Intervention Type: DEVICE

IVUS

intravascular ultrasound

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

Intervention Type: DEVICE

Other Intervention Names

Radi Pressure Wire(Radi Medical Systems, Uppsala, Sweden); iLab® Ultrasound Imaging System(Boston Scientific/SCIMED, Minneapolis, MN, USA)

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University hospital

Principal Investigators

Bon-kwon Koo, MD/PhD

Role: STUDY_DIRECTOR

Seoul National University Hospital

References

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.

Reference Type: DERIVED

PMID: 22516397 (View on PubMed)

Other Identifiers

Bif_3

Identifier Type: -

Identifier Source: org_study_id