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

Phase 4

• Conditions: Coronary Heart Disease
• Interventions: Device: Promus element, Xience prime, and Nobori

• Registration Number: NCT01942044
• Lead Sponsor: Kobe University

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.

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-09
• Study First Submitted: 2013-09-07
• Study First Submitted QC: 2013-09-10
• Last Update Submitted: 2013-09-10
• Study First Posted: 2013-09-13
• Last Update Posted: 2013-09-13
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Promus element	Promus element, Xience prime, and Nobori	Promus element is a thin struts, 2-link design, evelolimus-eluting stents.
Xience Prime	Promus element, Xience prime, and Nobori	Xience Prime is a thin struts, 3-link design, evelolimus-eluting stents.
Nobori	Promus element, Xience prime, and Nobori	Nobori is a thick struts, 2-link design, biolimus-eluting stents.

Primary Outcome Measures

Name	Time	Method
Percentage of uncovered struts	8 months

Secondary Outcome Measures

Name	Time	Method
Neointimal thickness	8 months
Area of low wall shear stress	8 months
The percentage of malapposed struts	8 months
Area of high oscillatory shear index	8 months

Trial Locations

Locations (1)

Kobe University Graduate School of Medicine; 🇯🇵 Kobe, Hyogo, Japan