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

Tracking Information

First Received Date ^ICMJE

August 12, 2012

Last Updated Date

March 16, 2013

Start Date ^ICMJE

March 2010

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01667757 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Coronary Disease

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Joon Hyung Doh, MDPhD

82-31-910-7830

joon.doh@gmail.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01667757

Other Study ID Numbers ^ICMJE

IB-2-1208-026

Has Data Monitoring Committee

Yes

Responsible Party

Joon Hyung Doh, Inje University

Study Sponsor ^ICMJE

Inje University

Collaborators ^ICMJE

Seoul National University Hospital

Investigators ^ICMJE

Principal Investigator:

Joon Hyung Doh, MDPhD

Inje University

Information Provided By

Inje University

Verification Date

March 2013

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

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