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

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

• Status: Unknown
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Procedure: kissing balloon inflation; Device: EES vs. SES

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

Study Locations

• Japan
  • 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: Yoshihisa Kinoshita, MD; Phone Number: +81-532-37-3377; Email: Ykinoshita@heart-center.or.jp
    • Principal Investigator: Yoshihisa Kinoshita, MD
  • Yokohama, Japan
    • Recruiting
    • Saiseikai Yokohama Eastern Hospital
    • Contact: Masahiro Yamawaki, MD, PhD; Email: m_yamawaki@tobu.saiseikai.or.jp
    • Principal Investigator: Masahiro Yamawaki, MD, PhD
  • Yukuhashi, Japan, 824-0026
    • Recruiting
    • New Yukuhashi hospital
    • Contact: Yoshinobu Murasato, MD, PhD; Phone Number: +81-930-24-8899; Email: murasato@shinyukuhashihospital.or.jp
    • Principal Investigator: Yoshinobu Murasato, MD, PhD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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.	Procedure: kissing balloon inflation; Kissing balloon inflation following the MV stenting; Device: EES vs. SES; 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.	Procedure: kissing balloon inflation; Kissing balloon inflation following the MV stenting; Device: EES vs. SES; 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.	Procedure: kissing balloon inflation; Kissing balloon inflation following the MV stenting; Device: EES vs. SES; 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.	Procedure: kissing balloon inflation; Kissing balloon inflation following the MV stenting; Device: EES vs. SES; 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	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	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

• Sponsor: Shin Yukuhashi Hospital
• Collaborators: Abbott Medical Devices; Cordis Corporation
• Investigators: Principal Investigator: Yoshinobu Murasato, MD, PhD, New Yukuhashi hospital; Principal Investigator: Yoshihisa Kinoshita, MD, Toyohashi Heart Center

Study record dates

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

• Keywords: Bifurcation lesion, drug-eluting stent, symmetric expansion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: J-REVERSE

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