- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01266239
Comparison Between Everolimus-eluting Stent (EES) and Sirolimus-eluting Stent (SES) in the Bifurcation Lesion (J-REVERSE)
December 23, 2010 updated by: Shin Yukuhashi Hospital
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."
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Kissing balloon inflation brings asymmetrical expansion which may lead to a risk of disturbance of endothelialization. We will investigate the following issues.
- Impact of asymmetric expansion induced by kissing balloon technique on mid and long term results
- Difference between SES and EES
- Impact of abnormal OCT findings on long-term clinical outcome (3yr)
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yoshinobu Murasato, MD, PhD
- Phone Number: +81-930-24-8899
- Email: murasato@shinyukuhashihospital.or.jp
Study Contact Backup
- Name: Yoshihisa Kinoshita, MD
- Phone Number: +81-532-37-3377
- Email: Ykinoshita@heart-center.or.jp
Study Locations
-
-
-
Kobe, Japan
- Recruiting
- Kobe University
-
Contact:
- Toshiro Shinke, MD, PhD
-
Principal Investigator:
- Toshiro Shinke, MD, PhD
-
Sub-Investigator:
- Hiromasa Otake, MD, PhD
-
Nishinomiya, Japan
- Recruiting
- Hyogo Medical University
-
Contact:
- Kenichi Fujii, MD, PhD
-
Principal Investigator:
- Kenichi Fujii, MD, PhD
-
Toyohashi, Japan
- Recruiting
- Toyohashi Heart Center
-
Contact:
- Yoshihisa Kinoshita, MD
- Phone Number: +81-532-37-3377
- Email: Ykinoshita@heart-center.or.jp
-
Principal Investigator:
- Yoshihisa Kinoshita, MD
-
Yokohama, Japan
- Recruiting
- Saiseikai Yokohama Eastern Hospital
-
Contact:
- Masahiro Yamawaki, MD, PhD
- Email: m_yamawaki@tobu.saiseikai.or.jp
-
Principal Investigator:
- Masahiro Yamawaki, MD, PhD
-
Yukuhashi, Japan, 824-0026
- Recruiting
- New Yukuhashi hospital
-
Contact:
- Yoshinobu Murasato, MD, PhD
- Phone Number: +81-930-24-8899
- Email: murasato@shinyukuhashihospital.or.jp
-
Principal Investigator:
- Yoshinobu Murasato, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Coronary bifurcation lesion which stenotic lesion exists in the MV and / or in the side branch (SB).
- The lesion is appropriate for the provisional MV stenting.
- The reference diameter is more than 2.5mm in the MV and more than 2.0mm in the SB.
Exclusion Criteria:
- Left main coronary bifurcation
- Acute myocardial infarction and unstable angina which culprit vessel contains obvious thrombus
- Left ventricular ejection fraction < 30%
- Shock state
- Inappropriate candidate for the dual antiplatelet therapy, administration of contrast medium and radiation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Kissing balloon inflation following the MV stenting
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.
|
Kissing balloon inflation following the MV stenting
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.
|
Kissing balloon inflation following the MV stenting
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.
|
Kissing balloon inflation following the MV stenting
Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiac events
Time Frame: 3 years
|
Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
abnormal intimal coverage
Time Frame: 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.
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yoshinobu Murasato, MD, PhD, New Yukuhashi hospital
- Principal Investigator: Yoshihisa Kinoshita, MD, Toyohashi Heart Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Anticipated)
July 1, 2012
Study Completion (Anticipated)
July 1, 2015
Study Registration Dates
First Submitted
December 22, 2010
First Submitted That Met QC Criteria
December 23, 2010
First Posted (Estimate)
December 24, 2010
Study Record Updates
Last Update Posted (Estimate)
December 24, 2010
Last Update Submitted That Met QC Criteria
December 23, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- J-REVERSE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ischemic Heart Disease
-
Genzyme, a Sanofi CompanyTerminatedIschemic Heart Disease | Ischemic Cardiomyopathy | Ischemic Heart FailureBelgium, France, Germany, Italy, Switzerland, United Kingdom
-
University of AlbertaRecruitingCoronary Artery Disease | Stable Ischemic Heart Disease | Beta-blocker TherapyCanada
-
Gerencia de Atención Primaria, MadridServicio Canario de Salud; Avedis Donabedian Research InstituteCompletedIschemic Heart Disease ChronicSpain
-
Michael SekelaCompletedChronic Ischemic Heart DiseaseUnited States
-
Rigshospitalet, DenmarkNot yet recruitingChronic Ischemic Heart DiseaseDenmark
-
Cardiocentro TicinoTerminatedChronic Ischemic Heart DiseaseSwitzerland
-
University of PecsCompleted
-
The University of Texas Health Science Center,...National Heart, Lung, and Blood Institute (NHLBI); Cardiovascular Cell Therapy...CompletedIschemic Cardiomyopathy | Left Ventricular Dysfunction | Angina | Chronic Ischemic Heart DiseaseUnited States
-
Affiliated Hospital to Academy of Military Medical...Ivy Institute of Stem Cells Co. LtdUnknownHeart Failure | Angina | Chronic Ischemic Heart DiseaseChina
-
University of EdinburghUnknown
Clinical Trials on kissing balloon inflation
-
Seoul National University HospitalUnknownThroat Pain After EUS Insertion
-
Vastra Gotaland RegionRecruiting
-
Dalian UniversityCompletedCoronary Artery DiseaseChina
-
Prof. Dr. med. Gunnar TepeZeller; Duda; Albrecht; Reimer; Brechtel; Diehm; Strausinsky; Jahnke; Huppert; AmendtUnknown
-
Istanbul Mehmet Akif Ersoy Educational and Training...Active, not recruitingCoronary Artery DiseaseTurkey
-
University of Texas Southwestern Medical CenterAstraZenecaTerminatedIschemic PreconditioningUnited States
-
University of Witten/HerdeckeNot yet recruitingVenipuncture
-
Central Arkansas Veterans Healthcare SystemNot yet recruitingCoronary Artery Disease | Coronary Stent OcclusionUnited States
-
King's College LondonKing's College Hospital NHS TrustCompleted
-
Istanbul Mehmet Akif Ersoy Educational and Training...Not yet recruiting