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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01667757

Enrollment

200

Registered

2012-08-17

Start date

2010-03-31

Completion date

2014-12-31

Last updated

2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

coronary atherosclerosis, drug eluting stent, intravascular ultrasound, fractional flow reserve

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results