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OpenTrials
Completed

NCT Number: NCT01335659

Main Branch Versus Side Branch Ostial Lesion

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

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Key information

Conditions

Coronary Artery Stenosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractional flow reserve

Device

Fractional flow reserve measured by pressure wire

Other names: Radi Pressure Wire(Radi Medical Systems, Uppsala, Sweden)

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

Other names: iLab® Ultrasound Imaging System(Boston Scientific/SCIMED, Minneapolis, MN, USA)

Primary outcomes

  1. lumen area

    Time frame: 1 day

    lumen area at ostial lesion

Secondary outcomes

  1. angiographic stenosis, % plaque area

    Time frame: 1 day

    angiographic and intravascular ultrasound parameters at ostial lesions of each major branch and side branch.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Relationship Between Fractional Flow Reserve and Coronary Angiography/Intravascular Ultrasound Parameters in Ostial Lesions: Major Coronary Ostial Lesions Versus Side Branch Ostial Lesions

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 14, 2011
Registry last updated
Jul 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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