Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents

NCT ID: NCT01073111

Last Updated: 2018-08-03

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2017-02-28

Brief Summary

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The purpose of this study is to compare coronary endothelium function in patients with a zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical coherence tomography, vasoconstriction in response to acetylcholine, and coronary biomarker level.

Detailed Description

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Conditions

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Coronary Artery Disease Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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zotarolimus-eluting stents (ENDEAVOR®)

Group Type ACTIVE_COMPARATOR

zotarolimus-eluting stent (ENDEAVOR®)

Intervention Type DEVICE

zotarolimus-eluting stent

sirolimus-eluting stents (CYPHER SELECT® PLUS)

Group Type ACTIVE_COMPARATOR

sirolimus-eluting stents (CYPHER SELECT® PLUS)

Intervention Type DEVICE

sirolimus-eluting stents

everolimus-eluting stents (PROMUS®)

Group Type ACTIVE_COMPARATOR

everolimus-eluting stents (PROMUS®)

Intervention Type DEVICE

everolimus-eluting stents

Interventions

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zotarolimus-eluting stent (ENDEAVOR®)

zotarolimus-eluting stent

Intervention Type DEVICE

sirolimus-eluting stents (CYPHER SELECT® PLUS)

sirolimus-eluting stents

Intervention Type DEVICE

everolimus-eluting stents (PROMUS®)

everolimus-eluting stents

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis)
* Patients with stable or acute coronary syndrome considered for coronary revascularization
* Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion Criteria

* Contraindication to anti-platelet agents
* Ostial lesion within 5 mm from ostium
* Different DES in other vessel simultaneously
* Creatinine level 2.5 mg/dL
* Left main stenosis more than 50%.
* vein graft lesion
* Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
* Life expectancy 1 year
* Reference vessel \< 2.5 mm or \> 4.0 mm diameter by visual
* Long lesion that require more than three stents
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hyogo Medical University

OTHER

Sponsor Role lead

Responsible Party

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Kenichi Fujii

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hyogo College of Medicine

Nishinomiya, , Japan

Site Status

Countries

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Japan

Other Identifiers

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ASSESS

Identifier Type: -

Identifier Source: org_study_id

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