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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01266239

Acronym

J-REVERSE

Enrollment

300

Registered

2010-12-24

Start date

2010-07-31

Completion date

2015-07-31

Last updated

2010-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Keywords

Bifurcation lesion, drug-eluting stent, symmetric expansion

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)

Interventions

PROCEDUREkissing balloon inflation

Kissing balloon inflation following the MV stenting

DEVICEEES vs. SES

Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Japan

Contacts

Primary ContactYoshinobu Murasato, MD, PhD

murasato@shinyukuhashihospital.or.jp+81-930-24-8899

Backup ContactYoshihisa Kinoshita, MD

Ykinoshita@heart-center.or.jp+81-532-37-3377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026