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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Promus element, Xience prime, and Nobori


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 20 years old. Indication of PCI with Xience prime, Nobori, or Promus element. Clinical diagnosis of stable angina, unstable angina or silent ischemia with reference vessel diameters ranging from 2.5-3.5mm. Underwent CT angiography before PCI. To agree to review and record all the clinical course in this research protocol. Exclusion Criteria: Previous history of pancytopenia, liver function, renal dysfunction, hypersensitive history of the drug. Low ejection fraction (LVEF<=30%), an impaired liver function, and renal dysfunction (eGFR<=40) Severe calcification Stent restenosis

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Promus element<br>Promus element is a thin struts, 2-link design, evelolimus-eluting stents. | Device: Promus element, Xience prime, and Nobori<br> <br> |
| Active Comparator: Xience Prime<br>Xience Prime is a thin struts, 3-link design, evelolimus-eluting stents. | Device: Promus element, Xience prime, and Nobori<br> <br> |
| Active Comparator: Nobori<br>Nobori is a thick struts, 2-link design, biolimus-eluting stents. | Device: Promus element, Xience prime, and Nobori<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of uncovered struts |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neointimal thickness |  | 8 months | 
| The percentage of malapposed struts |  | 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. | 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. | Baseline | 
| Area of low wall shear stress |  | 8 months | 
| Area of high oscillatory shear index |  | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shear stress, Optical coherence tomography, Drug-eluting stents