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OpenTrials
Completed

NCT Number: NCT01667757

Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent 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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Key information

Conditions

Coronary Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Inje University Ilsan Paik Hospital

Goyang, Gyeonggido, 411-709, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Inje University

Other

Collaborators

  • Seoul National University Hospital

Registry information

Official study title

Angiographic and IVUS Criteria Defining Physiologic Optimization By the Fractional Flow Reserve After DES Implantation

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Aug 17, 2012
Registry last updated
Mar 24, 2015

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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