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Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation

This study is currently recruiting participants.
Verified March 2013 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: March 16, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Angiographic and IVUS Criteria Defining Physiologic Optimization By the Fractional Flow Reserve After DES Implantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667757

Contacts
Contact: Joon Hyung Doh, MDPhD 82-31-910-7830 joon.doh@gmail.com

Locations
Korea, Republic of
Inje University Ilsan Paik Hospital Recruiting
Goyang, Gyeonggido, Korea, Republic of, 411-709
Contact: Joon Hyung Doh, MDPhD     82-31-910-7830     joon.doh@gmail.com    
Contact: Bon-Kwon Koo, MDPhD         bkkoo@snu.ac.kr    
Principal Investigator: Joon Hyung Doh, MDPhD            
Sponsors and Collaborators
Inje University
Seoul National University Hospital
Investigators
Principal Investigator: Joon Hyung Doh, MDPhD Inje University
  More Information

Publications:

Responsible Party: Joon Hyung Doh, MD, PHD, Inje University
ClinicalTrials.gov Identifier: NCT01667757     History of Changes
Other Study ID Numbers: IB-2-1208-026
Study First Received: August 12, 2012
Last Updated: March 16, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Inje University:
coronary atherosclerosis
drug eluting stent
intravascular ultrasound
fractional flow reserve

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 23, 2013