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

NCT ID: NCT01942044

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-02-28

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.

Conditions

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Coronary Heart Disease

Keywords

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Shear stress Optical coherence tomography Drug-eluting stents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Promus element

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

Group Type EXPERIMENTAL

Promus element, Xience prime, and Nobori

Intervention Type DEVICE

Xience Prime

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

Group Type ACTIVE_COMPARATOR

Promus element, Xience prime, and Nobori

Intervention Type DEVICE

Nobori

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

Group Type ACTIVE_COMPARATOR

Promus element, Xience prime, and Nobori

Intervention Type DEVICE

Interventions

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Promus element, Xience prime, and Nobori

Intervention Type DEVICE

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marquette University

OTHER

Sponsor Role collaborator

Kobe University

INDUSTRY

Sponsor Role lead

Responsible Party

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Hiromasa Otake

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hiromasa Otake, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kobe University Graduate School of Medicine

Locations

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Kobe University Graduate School of Medicine

Kobe, Hyōgo, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Hiromasa Otake, MD, PhD

Role: CONTACT

Phone: +81.78.382.5846

Email: [email protected]

Facility Contacts

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Hiromasa Otake, MD, PhD

Role: primary

Other Identifiers

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HOtake1

Identifier Type: -

Identifier Source: org_study_id