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

Primary Purpose

Ischemic Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
kissing balloon inflation
EES vs. SES
Sponsored by
Shin Yukuhashi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Bifurcation lesion, drug-eluting stent, symmetric expansion

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kobe UniversityRecruiting
  • Hyogo Medical UniversityRecruiting
  • Toyohashi Heart CenterRecruiting
  • Saiseikai Yokohama Eastern HospitalRecruiting
  • New Yukuhashi hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

SES-KB

SES-NK

EES-KB

EES-NK

Arm Description

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

SES is deployed in the MV without kissing balloon inflation.

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

EES is deployed in the MV without kissing balloon inflation.

Outcomes

Primary Outcome Measures

Major adverse cardiac events
Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored.

Secondary Outcome Measures

abnormal intimal coverage
Optical coherence tomography (OCT) is planned at the 9-month follow-up period. Unevenness of intimal growth, number of uncovered struts, and frequency of thrombus attachment are evaluated.

Full Information

First Posted
December 22, 2010
Last Updated
December 23, 2010
Sponsor
Shin Yukuhashi Hospital
Collaborators
Abbott Medical Devices, Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01266239
Brief Title
Comparison Between Everolimus-eluting Stent (EES) and Sirolimus-eluting Stent (SES) in the Bifurcation Lesion
Acronym
J-REVERSE
Official Title
Japanese Registry Study in Comparison Between Everolimus-eluting Stent and Sirolimus-eluting Stent for the Bifurcation Lesion
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shin Yukuhashi Hospital
Collaborators
Abbott Medical Devices, Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Kissing balloon inflation brings asymmetrical expansion which may lead to a risk of disturbance of endothelialization. We will investigate the following issues. Impact of asymmetric expansion induced by kissing balloon technique on mid and long term results Difference between SES and EES Impact of abnormal OCT findings on long-term clinical outcome (3yr)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
Bifurcation lesion, drug-eluting stent, symmetric expansion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SES-KB
Arm Type
Active Comparator
Arm Description
Sirolimus-eluting stent (SES) is deployed in the main vessel (MV)and subsequent kissing balloon inflation is performed in the bifurcation.
Arm Title
SES-NK
Arm Type
Active Comparator
Arm Description
SES is deployed in the MV without kissing balloon inflation.
Arm Title
EES-KB
Arm Type
Active Comparator
Arm Description
Everolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation.
Arm Title
EES-NK
Arm Type
Active Comparator
Arm Description
EES is deployed in the MV without kissing balloon inflation.
Intervention Type
Procedure
Intervention Name(s)
kissing balloon inflation
Intervention Description
Kissing balloon inflation following the MV stenting
Intervention Type
Device
Intervention Name(s)
EES vs. SES
Intervention Description
Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.
Primary Outcome Measure Information:
Title
Major adverse cardiac events
Description
Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
abnormal intimal coverage
Description
Optical coherence tomography (OCT) is planned at the 9-month follow-up period. Unevenness of intimal growth, number of uncovered struts, and frequency of thrombus attachment are evaluated.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Coronary bifurcation lesion which stenotic lesion exists in the MV and / or in the side branch (SB). The lesion is appropriate for the provisional MV stenting. The reference diameter is more than 2.5mm in the MV and more than 2.0mm in the SB. Exclusion Criteria: Left main coronary bifurcation Acute myocardial infarction and unstable angina which culprit vessel contains obvious thrombus Left ventricular ejection fraction < 30% Shock state Inappropriate candidate for the dual antiplatelet therapy, administration of contrast medium and radiation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoshinobu Murasato, MD, PhD
Phone
+81-930-24-8899
Email
murasato@shinyukuhashihospital.or.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Yoshihisa Kinoshita, MD
Phone
+81-532-37-3377
Email
Ykinoshita@heart-center.or.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshinobu Murasato, MD, PhD
Organizational Affiliation
New Yukuhashi Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoshihisa Kinoshita, MD
Organizational Affiliation
Toyohashi Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kobe University
City
Kobe
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshiro Shinke, MD, PhD
First Name & Middle Initial & Last Name & Degree
Toshiro Shinke, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hiromasa Otake, MD, PhD
Facility Name
Hyogo Medical University
City
Nishinomiya
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenichi Fujii, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kenichi Fujii, MD, PhD
Facility Name
Toyohashi Heart Center
City
Toyohashi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshihisa Kinoshita, MD
Phone
+81-532-37-3377
Email
Ykinoshita@heart-center.or.jp
First Name & Middle Initial & Last Name & Degree
Yoshihisa Kinoshita, MD
Facility Name
Saiseikai Yokohama Eastern Hospital
City
Yokohama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masahiro Yamawaki, MD, PhD
Email
m_yamawaki@tobu.saiseikai.or.jp
First Name & Middle Initial & Last Name & Degree
Masahiro Yamawaki, MD, PhD
Facility Name
New Yukuhashi hospital
City
Yukuhashi
ZIP/Postal Code
824-0026
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshinobu Murasato, MD, PhD
Phone
+81-930-24-8899
Email
murasato@shinyukuhashihospital.or.jp
First Name & Middle Initial & Last Name & Degree
Yoshinobu Murasato, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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