The purpose of this study is to evaluate the differences of wall shear stress distribution among different types of drug-eluting stents and its impact on vessel healing evaluated by intravascular optical coherence tomography evaluation.
Background: Distribution of wall shear stress (WSS) may be different according to stent designs. The impact of WSS after stent implantation may impact future vessel healing after current generation drug-eluting stents implantation. Although previous studies used IVUS (intravascular ultrasound) and angiography to determine WSS from computational fluid dynamics (CFD) simulations, new methods using higher resolution OCT (optical coherence tomography) are warranted to further evaluate the impact of stent design on WSS with current generation drug-eluting stents. Methods: For these purpose, we will enroll a total of 30 patients with stable angina who are scheduled for percutaneous coronary intervention. Those patients were randomized to thin-strut (81μm) 2-link Promus element (PE: n=10), thin-strut (81μm) 3-link Xience Prime (XP: n=10), or thick-strut (145μm) 2-link Nobori stents (NO: n=10) and underwent OCT and coronary CT angiography (CTA) after stenting. Post stent WSS was calculated using CFD simulations based on patient-specific reconstructed 3D arteries created by the fusion of OCT and CTA data, normalized using WSS in the proximal unstented region. Also, follow-up angiography and OCT are performed for the assessment of vessel healing as well as WSS distribution 8months after stent implantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Kobe University Graduate School of Medicine
Kobe, Hyōgo, Japan
RECRUITINGPercentage of uncovered struts
Time frame: 8 months
Neointimal thickness
Time frame: 8 months
The percentage of malapposed struts
Time frame: 8 months
Area of low wall shear stress
Baseline area of low wall shear stress will be calculated within 1 month after obtaining post stent OCT and CTA images.
Time frame: Baseline
Area of high oscillatory shear index
Baseline area of high oscillatory shear index will be calculated within 1 month after obtaining post stent OCT and CTA images.
Time frame: Baseline
Area of low wall shear stress
Time frame: 8 months
Area of high oscillatory shear index
Time frame: 8 months
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