Ischemic Heart DiseaseJ-REVERSENCT01266239
Comparison Between Everolimus-eluting Stent (EES) and Sirolimus-eluting Stent (SES) in the Bifurcation Lesion
A study testing kissing balloon inflation and EES vs. SES in people with Ischemic Heart Disease, run by Shin Yukuhashi Hospital at 5 sites in Japan.
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." Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- kissing balloon inflation and EES vs. SES
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesJapan
- Study dates
- Jul 2010to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites, 5 recruiting
- Recruiting
Kobe University
Kobe
Toshiro Shinke, MD, PhD
Toshiro Shinke, MD, PhD
- Recruiting
Hyogo Medical University
Nishinomiya
Kenichi Fujii, MD, PhD
Kenichi Fujii, MD, PhD
- Recruiting
Toyohashi Heart Center
Toyohashi
Yoshihisa Kinoshita, MD, +81-532-37-3377, Ykinoshita@heart-center.or.jp
Yoshihisa Kinoshita, MD
- Recruiting
Saiseikai Yokohama Eastern Hospital
Yokohama
Masahiro Yamawaki, MD, PhD, m_yamawaki@tobu.saiseikai.or.jp
Masahiro Yamawaki, MD, PhD
- Recruiting
New Yukuhashi hospital
Yukuhashi, 824-0026
Yoshinobu Murasato, MD, PhD, +81-930-24-8899, murasato@shinyukuhashihospital.or.jp
Yoshinobu Murasato, MD, PhD
About this study
Official title: 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."
Read the 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)
- Conditions
- Ischemic Heart Disease
- Being tested
- kissing balloon inflation, EES vs. SES
- Keywords
- Bifurcation lesion, drug-eluting stent, symmetric expansion
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kissing balloon inflationProcedure or surgery
Kissing balloon inflation following the MV stenting
EES vs. SESDevice
Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.
| Study group | Role | What they receive |
|---|---|---|
| SES-KB | Active comparator | Sirolimus-eluting stent (SES) is deployed in the main vessel (MV)and subsequent kissing balloon inflation is performed in the bifurcation. Receives: Procedure: kissing balloon inflation; Device: EES vs. SES |
| SES-NK | Active comparator | SES is deployed in the MV without kissing balloon inflation. Receives: Procedure: kissing balloon inflation; Device: EES vs. SES |
| EES-KB | Active comparator | Everolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation. Receives: Procedure: kissing balloon inflation; Device: EES vs. SES |
| EES-NK | Active comparator | EES is deployed in the MV without kissing balloon inflation. Receives: Procedure: kissing balloon inflation; Device: EES vs. SES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2012 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Yukuhashi Hospital
- Sponsor type
- Research network
- Collaborators
- Abbott Medical Devices, Cordis US Corp.
- Investigators
- Yoshinobu Murasato, MD, PhD, Principal investigator, New Yukuhashi HospitalYoshihisa Kinoshita, MD, Principal investigator, Toyohashi Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266239
- Sponsor's protocol ID
- J-REVERSE
- Acronym
- J-REVERSE
- Status last verified
- Dec 2010
- First submitted
- 22 Dec 2010
- Last updated
- 24 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japanese Registry Study in Comparison Between Everolimus-eluting Stent and Sirolimus-eluting Stent for the Bifurcation Lesion
- ClinicalTrials.gov ID
- NCT01266239
- Acronym / sponsor ID
- J-REVERSE / J-REVERSE
- Conditions
- Ischemic Heart Disease
- Keywords
- Bifurcation lesion, drug-eluting stent, symmetric expansion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shin Yukuhashi HospitalResearch network
- Collaborators
- Abbott Medical Devices, Cordis US Corp.
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 24 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SES-KB | Active comparator | Procedure: kissing balloon inflation, Device: EES vs. SESSirolimus-eluting stent (SES) is deployed in the main vessel (MV)and subsequent kissing balloon inflation is performed in the bifurcation. |
| SES-NK | Active comparator | Procedure: kissing balloon inflation, Device: EES vs. SESSES is deployed in the MV without kissing balloon inflation. |
| EES-KB | Active comparator | Procedure: kissing balloon inflation, Device: EES vs. SESEverolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation. |
| EES-NK | Active comparator | Procedure: kissing balloon inflation, Device: EES vs. SESEES is deployed in the MV without kissing balloon inflation. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kissing balloon inflationKissing balloon inflation following the MV stenting | Procedure or surgery | EES-KB, EES-NK, SES-KB, SES-NK |
| EES vs. SESRapid endothelialization after EES deployment has been reported compared to that after SES deployment. | Device | EES-KB, EES-NK, SES-KB, SES-NK |
Primary outcome
Major adverse cardiac events
Time frame: 3 years
Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored.
1 secondary outcome
abnormal intimal coverage
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshinobu Murasato, MD, PhD principal investigator
New Yukuhashi Hospital
Yoshihisa Kinoshita, MD principal investigator
Toyohashi Heart Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kissing balloon inflation and EES vs. SES in people with Ischemic Heart Disease, run by Shin Yukuhashi Hospital at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoshinobu Murasato, MD, PhD (+81-930-24-8899, murasato@shinyukuhashihospital.or.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2010.