Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01667757
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : March 24, 2015
Seoul National University Hospital
Information provided by (Responsible Party):
Joon Hyung Doh, Inje University

August 12, 2012
August 17, 2012
March 24, 2015
March 2010
December 2013   (Final data collection date for primary outcome measure)
Differences angiographic and IVUS parameters after DES between different FFR groups [ Time Frame: baseline ]
Angiographic residual percent diameter stenosis (%), minimal stent lumen diameter (mm) and total stent length (mm), and IVUS minimal stent cross-sectional area (mm2) and minimal stent lumen diameter (mm) will be compared according to different FFR groups at the time of measurement after DES implantation.
Same as current
Complete list of historical versions of study NCT01667757 on Archive Site
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Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation
Angiographic and IVUS Criteria Defining Physiologic Optimization By the Fractional Flow Reserve After DES Implantation
Invasive imaging criteria of the Coronary arteriography (CAG) and intravascular ultrasound imaging (IVUS), satisfying procedural optimization after drug eluting stent (DES) implantation, were used in < 10% DS by CAG and 5-5.5mm2 MSA by IVUS. Whether these criteria satisfy not only relieving visible stenosis but also relieving lesion specific ischemia or not were unclear. Fractional flow reserve (FFR), an index of lesion specific ischemia, was proposed 0.9 as a physiologic criteria satisfying successful stent implantation by previous studies with bare metal stent. FFR after drug-eluting stent implantation can be an useful predictor for clinical outcome. But, direct comparative evaluation of the invasive imaging criteria defining as an indicator relieving myocardial ischemia were not reported. The aim of this study was to investigate angiographic and IVUS parameters in which corresponding FFR and evaluate their optimal physiologic criteria after DES implantation.
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Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Probability Sample
Patients who underwent coronary angiography and percutaneous coronary intervention for the diagnosis and treatment purposes because of clinical angina pectoris. Patient who underwent simultaneous IVUS and FFR measurement after DES implantation would be enrolled consecutively.
Coronary Disease
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  • low post DES FFR group (<0.9)
    the patient with FFR values less than 0.9 after DES procedure
  • high post DES FFR group (≥0.9)
    the patient with FFR values greater than 0.9 after DES procedure

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2014
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • clinical angina pectoris who underwent IVUS and FFR during coronary angiography and after DES implantation.
  • agree with informed consent
  • At least one segment of three major epicardial coronary arteries were consecutively enrolled in invasive CAG.
  • Post- stent FFR and IVUS measurement performed at the immediately after whole PCI procedures.

Exclusion Criteria:

  • unable to get informed consent
  • low left ventricular ejection fraction less than 35%
  • chronic renal failure (Cr > 2.0mg/dl)
  • acute myocardial infarction related coronary artery
  • allergy to adenosine injection
Sexes Eligible for Study: All
20 Years to 85 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Joon Hyung Doh, Inje University
Inje University
Seoul National University Hospital
Principal Investigator: Joon Hyung Doh, MDPhD Inje University
Inje University
March 2015