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

Ischemic Heart Disease Clinical Trial

— J-REVERSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01266239
• Other study ID #: J-REVERSE
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2010
• Last updated: December 23, 2010
• Start date: July 2010
• Est. completion date: July 2015

Study information

• Verified date: December 2010
• Source: Shin Yukuhashi Hospital
• Contact: Yoshinobu Murasato, MD, PhD
• Phone: +81-930-24-8899
• Email: murasato[@]shinyukuhashihospital.or.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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."

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2015
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Japan	Kobe University	Kobe
Japan	Hyogo Medical University	Nishinomiya
Japan	Toyohashi Heart Center	Toyohashi
Japan	Saiseikai Yokohama Eastern Hospital	Yokohama
Japan	New Yukuhashi hospital	Yukuhashi

Sponsors (3)

Lead Sponsor	Collaborator
Shin Yukuhashi Hospital	Abbott Vascular, Cordis Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events	Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored.	3 years	Yes
Secondary	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	Yes