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

Kobe University

Status and phase: Unknown; Phase 4

Conditions: Coronary Heart Disease

Treatments: Device: Promus element, Xience prime, and Nobori

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01942044

HOtake1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Promus element

Experimental group

Description:

Promus element is a thin struts, 2-link design, evelolimus-eluting stents.

Treatment:

Device: Promus element, Xience prime, and Nobori

Xience Prime

Active Comparator group

Description:

Xience Prime is a thin struts, 3-link design, evelolimus-eluting stents.

Treatment:

Device: Promus element, Xience prime, and Nobori

Nobori

Active Comparator group

Description:

Nobori is a thick struts, 2-link design, biolimus-eluting stents.

Treatment:

Device: Promus element, Xience prime, and Nobori