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Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation

I

Inje University

Status

Completed

Conditions

Coronary Disease

Study type

Observational

Funder types

Other

Identifiers

NCT01667757
IB-2-1208-026

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

low post DES FFR group (<0.9)
Description:
the patient with FFR values less than 0.9 after DES procedure
high post DES FFR group (≥0.9)
Description:
the patient with FFR values greater than 0.9 after DES procedure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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