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Relation Among Shear Stress Distribution, Stent Design, and Subsequent Vessel Healing After Drug-eluting Stent Implantation (SHEAR DES)

Coronary Heart Disease Clinical Trial

Official title:
Impact of Stent Platform on Shear Stress Distribution and Subsequent Vessel Healing After Drug-eluting Stent Implantation (SHEAR DES)

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01942044
Study type Interventional
Source Kobe University
Contact Hiromasa Otake, MD, PhD
Phone +81.78.382.5846
Email hotake@med.kobe-u.ac.jp
Status Recruiting
Phase Phase 4
Start date February 2013
Completion date February 2015
View Details
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