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

December 22, 2010
December 23, 2010
July 2010
July 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01266239 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Comparison Between Everolimus-eluting Stent (EES) and Sirolimus-eluting Stent (SES) in the Bifurcation Lesion
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."

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)
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Heart Disease
  • 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-KB
    Sirolimus-eluting stent (SES) is deployed in the main vessel (MV)and subsequent kissing balloon inflation is performed in the bifurcation.
    Interventions:
    • Procedure: kissing balloon inflation
    • Device: EES vs. SES
  • Active Comparator: SES-NK
    SES is deployed in the MV without kissing balloon inflation.
    Interventions:
    • Procedure: kissing balloon inflation
    • Device: EES vs. SES
  • Active Comparator: EES-KB
    Everolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation.
    Interventions:
    • Procedure: kissing balloon inflation
    • Device: EES vs. SES
  • Active Comparator: EES-NK
    EES is deployed in the MV without kissing balloon inflation.
    Interventions:
    • Procedure: kissing balloon inflation
    • Device: EES vs. SES
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
July 2015
July 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 85 Years
No
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
Japan
 
NCT01266239
J-REVERSE
Yes
Yoshinobu Murasato, New Yukuhashi Hospital
Shin Yukuhashi Hospital
  • Abbott Vascular
  • Cordis Corporation
Principal Investigator: Yoshinobu Murasato, MD, PhD New Yukuhashi Hospital
Principal Investigator: Yoshihisa Kinoshita, MD Toyohashi Heart Center
Shin Yukuhashi Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP