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| Name | Class |
|---|---|
| Marquette University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promus element | Experimental | Promus element is a thin struts, 2-link design, evelolimus-eluting stents. |
|
| Xience Prime | Active Comparator | Xience Prime is a thin struts, 3-link design, evelolimus-eluting stents. |
|
| Nobori | Active Comparator | Nobori is a thick struts, 2-link design, biolimus-eluting stents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promus element, Xience prime, and Nobori | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of uncovered struts | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neointimal thickness | 8 months | |
| The percentage of malapposed struts | 8 months | |
| Area of low wall shear stress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiromasa Otake, MD, PhD | Contact | +81.78.382.5846 | hotake@med.kobe-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Hiromasa Otake, MD, PhD | Kobe University Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe University Graduate School of Medicine | Recruiting | Kobe | Hyōgo | 650-0017 | Japan |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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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 |