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Comparison Between Everolimus-eluting Stent (EES) and Sirolimus-eluting Stent (SES) in the Bifurcation Lesion

NCT ID: NCT01266239

Last Updated: 2010-12-24

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

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2015-07-31

Brief Summary

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In study-1, the purpose of this study is to compare the long-term outcome of provisional stenting between EES and SES deployment. In study-2, it is to prove the following hypothesis " Asymmetrical expansion in the bifurcation lesion leads to frequent inhomogeneous intimal growth on the strut and thrombus attachment."

Detailed Description

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Kissing balloon inflation brings asymmetrical expansion which may lead to a risk of disturbance of endothelialization. We will investigate the following issues.

1. Impact of asymmetric expansion induced by kissing balloon technique on mid and long term results
2. Difference between SES and EES
3. Impact of abnormal OCT findings on long-term clinical outcome (3yr)

Conditions

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Ischemic Heart Disease

Keywords

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Bifurcation lesion, drug-eluting stent, symmetric expansion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SES-KB

Sirolimus-eluting stent (SES) is deployed in the main vessel (MV)and subsequent kissing balloon inflation is performed in the bifurcation.

Group Type ACTIVE_COMPARATOR

kissing balloon inflation

Intervention Type PROCEDURE

Kissing balloon inflation following the MV stenting

EES vs. SES

Intervention Type DEVICE

Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.

SES-NK

SES is deployed in the MV without kissing balloon inflation.

Group Type ACTIVE_COMPARATOR

kissing balloon inflation

Intervention Type PROCEDURE

Kissing balloon inflation following the MV stenting

EES vs. SES

Intervention Type DEVICE

Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.

EES-KB

Everolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation.

Group Type ACTIVE_COMPARATOR

kissing balloon inflation

Intervention Type PROCEDURE

Kissing balloon inflation following the MV stenting

EES vs. SES

Intervention Type DEVICE

Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.

EES-NK

EES is deployed in the MV without kissing balloon inflation.

Group Type ACTIVE_COMPARATOR

kissing balloon inflation

Intervention Type PROCEDURE

Kissing balloon inflation following the MV stenting

EES vs. SES

Intervention Type DEVICE

Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.

Interventions

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kissing balloon inflation

Kissing balloon inflation following the MV stenting

Intervention Type PROCEDURE

EES vs. SES

Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Coronary bifurcation lesion which stenotic lesion exists in the MV and / or in the side branch (SB).
2. The lesion is appropriate for the provisional MV stenting.
3. The reference diameter is more than 2.5mm in the MV and more than 2.0mm in the SB.

Exclusion Criteria

1. Left main coronary bifurcation
2. Acute myocardial infarction and unstable angina which culprit vessel contains obvious thrombus
3. Left ventricular ejection fraction \< 30%
4. Shock state
5. Inappropriate candidate for the dual antiplatelet therapy, administration of contrast medium and radiation
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role collaborator

Cordis Corporation

INDUSTRY

Sponsor Role collaborator

Shin Yukuhashi Hospital

NETWORK

Sponsor Role lead

Responsible Party

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New Yukuhashi Hospital

Principal Investigators

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Yoshinobu Murasato, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

New Yukuhashi Hospital

Yoshihisa Kinoshita, MD

Role: PRINCIPAL_INVESTIGATOR

Toyohashi Heart Center

Locations

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Kobe University

Kobe, , Japan

Site Status RECRUITING

Hyogo Medical University

Nishinomiya, , Japan

Site Status RECRUITING

Toyohashi Heart Center

Toyohashi, , Japan

Site Status RECRUITING

Saiseikai Yokohama Eastern Hospital

Yokohama, , Japan

Site Status RECRUITING

New Yukuhashi hospital

Yukuhashi, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Yoshinobu Murasato, MD, PhD

Role: CONTACT

Phone: +81-930-24-8899

Email: [email protected]

Yoshihisa Kinoshita, MD

Role: CONTACT

Phone: +81-532-37-3377

Email: [email protected]

Facility Contacts

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Toshiro Shinke, MD, PhD

Role: primary

Kenichi Fujii, MD, PhD

Role: primary

Yoshihisa Kinoshita, MD

Role: primary

Masahiro Yamawaki, MD, PhD

Role: primary

Yoshinobu Murasato, MD, PhD

Role: primary

Other Identifiers

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J-REVERSE

Identifier Type: -

Identifier Source: org_study_id