Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2010 by Shin Yukuhashi Hospital
Sponsor:
Collaborators:
Abbott Vascular
Cordis Corporation
Information provided by:
Shin Yukuhashi Hospital
ClinicalTrials.gov Identifier:
NCT01266239
First received: December 22, 2010
Last updated: December 23, 2010
Last verified: December 2010
  Purpose

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."


Condition Intervention
Ischemic Heart Disease
Procedure: kissing balloon inflation
Device: EES vs. SES

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Japanese Registry Study in Comparison Between Everolimus-eluting Stent and Sirolimus-eluting Stent for the Bifurcation Lesion

Resource links provided by NLM:


Further study details as provided by Shin Yukuhashi Hospital:

Primary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored.


Secondary Outcome Measures:
  • abnormal intimal coverage [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 300
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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)
  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266239

Contacts
Contact: Yoshinobu Murasato, MD, PhD +81-930-24-8899 murasato@shinyukuhashihospital.or.jp
Contact: Yoshihisa Kinoshita, MD +81-532-37-3377 Ykinoshita@heart-center.or.jp

Locations
Japan
Kobe University Recruiting
Kobe, Japan
Contact: Toshiro Shinke, MD, PhD         
Principal Investigator: Toshiro Shinke, MD, PhD         
Sub-Investigator: Hiromasa Otake, MD, PhD         
Hyogo Medical University Recruiting
Nishinomiya, Japan
Contact: Kenichi Fujii, MD, PhD         
Principal Investigator: Kenichi Fujii, MD, PhD         
Toyohashi Heart Center Recruiting
Toyohashi, Japan
Contact: Yoshihisa Kinoshita, MD    +81-532-37-3377    Ykinoshita@heart-center.or.jp   
Principal Investigator: Yoshihisa Kinoshita, MD         
Saiseikai Yokohama Eastern Hospital Recruiting
Yokohama, Japan
Contact: Masahiro Yamawaki, MD, PhD       m_yamawaki@tobu.saiseikai.or.jp   
Principal Investigator: Masahiro Yamawaki, MD, PhD         
New Yukuhashi hospital Recruiting
Yukuhashi, Japan, 824-0026
Contact: Yoshinobu Murasato, MD, PhD    +81-930-24-8899    murasato@shinyukuhashihospital.or.jp   
Principal Investigator: Yoshinobu Murasato, MD, PhD         
Sponsors and Collaborators
Shin Yukuhashi Hospital
Abbott Vascular
Cordis Corporation
Investigators
Principal Investigator: Yoshinobu Murasato, MD, PhD New Yukuhashi Hospital
Principal Investigator: Yoshihisa Kinoshita, MD Toyohashi Heart Center
  More Information

No publications provided

Responsible Party: Yoshinobu Murasato, New Yukuhashi Hospital
ClinicalTrials.gov Identifier: NCT01266239     History of Changes
Other Study ID Numbers: J-REVERSE
Study First Received: December 22, 2010
Last Updated: December 23, 2010
Health Authority: Japan: Institutional Review Board

Keywords provided by Shin Yukuhashi Hospital:
Bifurcation lesion, drug-eluting stent, symmetric expansion

Additional relevant MeSH terms:
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014