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Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Inje University
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by (Responsible Party):
Joon Hyung Doh, Inje University
ClinicalTrials.gov Identifier:
NCT01667757
First received: August 12, 2012
Last updated: May 12, 2014
Last verified: May 2014

August 12, 2012
May 12, 2014
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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov 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
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
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
Both
20 Years to 85 Years
No
Contact: Joon Hyung Doh, MDPhD 82-31-910-7830 joon.doh@gmail.com
Korea, Republic of
 
NCT01667757
IB-2-1208-026
Yes
Joon Hyung Doh, Inje University
Inje University
Seoul National University Hospital
Principal Investigator: Joon Hyung Doh, MDPhD Inje University
Inje University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP