Coronary Heart Disease
Conditions
Keywords
Shear stress, Optical coherence tomography, Drug-eluting stents
Brief 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.
Detailed 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.
Interventions
DEVICEPromus element, Xience prime, and Nobori
Sponsors
Marquette University
Kobe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of uncovered struts | 8 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neointimal thickness | 8 months | — |
| The percentage of malapposed struts | 8 months | — |
| Area of low wall shear stress | Baseline | Baseline area of low wall shear stress will be calculated within 1 month after obtaining post stent OCT and CTA images. |
| Area of high oscillatory shear index | Baseline | Baseline area of high oscillatory shear index will be calculated within 1 month after obtaining post stent OCT and CTA images. |
Countries
Japan
Contacts
Primary ContactHiromasa Otake, MD, PhD
Outcome results
None listed