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

December 23, 2010 updated by: Shin Yukuhashi Hospital

Japanese Registry Study in Comparison Between Everolimus-eluting Stent and Sirolimus-eluting Stent for the Bifurcation Lesion

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."

Study Overview

Detailed Description

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)

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Kobe, Japan
        • Recruiting
        • Kobe University
        • Contact:
          • Toshiro Shinke, MD, PhD
        • Principal Investigator:
          • Toshiro Shinke, MD, PhD
        • Sub-Investigator:
          • Hiromasa Otake, MD, PhD
      • Nishinomiya, Japan
        • Recruiting
        • Hyogo Medical University
        • Contact:
          • Kenichi Fujii, MD, PhD
        • Principal Investigator:
          • Kenichi Fujii, MD, PhD
      • Toyohashi, Japan
        • Recruiting
        • Toyohashi Heart Center
        • Contact:
        • Principal Investigator:
          • Yoshihisa Kinoshita, MD
      • Yokohama, Japan
        • Recruiting
        • Saiseikai Yokohama Eastern Hospital
        • Contact:
        • Principal Investigator:
          • Masahiro Yamawaki, MD, PhD
      • Yukuhashi, Japan, 824-0026
        • Recruiting
        • New Yukuhashi hospital
        • Contact:
        • Principal Investigator:
          • Yoshinobu Murasato, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SES-KB
Sirolimus-eluting stent (SES) is deployed in the main vessel (MV)and subsequent kissing balloon inflation is performed in the bifurcation.
Kissing balloon inflation following the MV stenting
Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.
Active Comparator: SES-NK
SES is deployed in the MV without kissing balloon inflation.
Kissing balloon inflation following the MV stenting
Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.
Active Comparator: EES-KB
Everolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation.
Kissing balloon inflation following the MV stenting
Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.
Active Comparator: EES-NK
EES is deployed in the MV without kissing balloon inflation.
Kissing balloon inflation following the MV stenting
Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events
Time Frame: 3 years
Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
abnormal intimal coverage
Time Frame: 9 months
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yoshinobu Murasato, MD, PhD, New Yukuhashi hospital
  • Principal Investigator: Yoshihisa Kinoshita, MD, Toyohashi Heart Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

December 22, 2010

First Submitted That Met QC Criteria

December 23, 2010

First Posted (Estimate)

December 24, 2010

Study Record Updates

Last Update Posted (Estimate)

December 24, 2010

Last Update Submitted That Met QC Criteria

December 23, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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