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

Not Applicable

• Conditions: Ischemic Heart Disease
• Interventions: Procedure: kissing balloon inflation; Device: EES vs. SES

• Registration Number: NCT01266239
• Lead Sponsor: Shin Yukuhashi Hospital

Brief 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."

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 Timeline

• Study Start: 2010-07
• Status Verified: 2010-12
• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-23
• Last Update Submitted: 2010-12-23
• Study First Posted: 2010-12-24
• Last Update Posted: 2010-12-24
• Primary Completion: 2012-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
SES-KB	EES vs. SES	Sirolimus-eluting stent (SES) is deployed in the main vessel (MV)and subsequent kissing balloon inflation is performed in the bifurcation.
SES-NK	kissing balloon inflation	SES is deployed in the MV without kissing balloon inflation.
SES-NK	EES vs. SES	SES is deployed in the MV without kissing balloon inflation.
SES-KB	kissing balloon inflation	Sirolimus-eluting stent (SES) is deployed in the main vessel (MV)and subsequent kissing balloon inflation is performed in the bifurcation.
EES-KB	kissing balloon inflation	Everolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation.
EES-KB	EES vs. SES	Everolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation.
EES-NK	kissing balloon inflation	EES is deployed in the MV without kissing balloon inflation.
EES-NK	EES vs. SES	EES is deployed in the MV without kissing balloon inflation.

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	3 years	Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored.

Secondary Outcome Measures

Name	Time	Method
abnormal intimal coverage	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.

Trial Locations

Locations (5)

Hyogo Medical University; 🇯🇵 Nishinomiya, Japan

Toyohashi Heart Center; 🇯🇵 Toyohashi, Japan

Kobe University; 🇯🇵 Kobe, Japan

Saiseikai Yokohama Eastern Hospital; 🇯🇵 Yokohama, Japan

New Yukuhashi hospital; 🇯🇵 Yukuhashi, Japan