Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation

Completed

• Conditions: Coronary Disease

• Registration Number: NCT01667757
• Lead Sponsor: Inje University

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 available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2012-08-12
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-17
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences angiographic and IVUS parameters after DES between different FFR groups	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.

Trial Locations

Locations (1)

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang, Gyeonggido, Korea, Republic of