Comparison Between Everolimus-eluting Stent (EES) and Sirolimus-eluting Stent (SES) in the Bifurcation Lesion (J-REVERSE)
This study is currently recruiting participants.
Verified December 2010 by Shin Yukuhashi Hospital
Sponsor:
Shin Yukuhashi Hospital
Collaborators:
Abbott Vascular
Cordis Corporation
Information provided by:
Shin Yukuhashi Hospital
ClinicalTrials.gov Identifier:
NCT01266239
First received: December 22, 2010
Last updated: December 23, 2010
Last verified: December 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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."
| Condition | Intervention |
|---|---|
|
Ischemic Heart Disease |
Procedure: kissing balloon inflation Device: EES vs. SES |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Japanese Registry Study in Comparison Between Everolimus-eluting Stent and Sirolimus-eluting Stent for the Bifurcation Lesion |
Resource links provided by NLM:
Further study details as provided by Shin Yukuhashi Hospital:
Primary Outcome Measures:
- Major adverse cardiac events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored.
Secondary Outcome Measures:
- abnormal intimal coverage [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
|
Active Comparator: SES-NK
SES is deployed in the MV without kissing balloon inflation.
|
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.
|
|
Active Comparator: EES-KB
Everolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation.
|
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.
|
|
Active Comparator: EES-NK
EES is deployed in the MV without kissing balloon inflation.
|
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.
|
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)
Eligibility| Ages Eligible for Study: | 20 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266239
Contacts
| Contact: Yoshinobu Murasato, MD, PhD | +81-930-24-8899 | murasato@shinyukuhashihospital.or.jp |
| Contact: Yoshihisa Kinoshita, MD | +81-532-37-3377 | Ykinoshita@heart-center.or.jp |
Locations
| Japan | |
| Kobe University | Recruiting |
| Kobe, Japan | |
| Contact: Toshiro Shinke, MD, PhD | |
| Principal Investigator: Toshiro Shinke, MD, PhD | |
| Sub-Investigator: Hiromasa Otake, MD, PhD | |
| Hyogo Medical University | Recruiting |
| Nishinomiya, Japan | |
| Contact: Kenichi Fujii, MD, PhD | |
| Principal Investigator: Kenichi Fujii, MD, PhD | |
| Toyohashi Heart Center | Recruiting |
| Toyohashi, Japan | |
| Contact: Yoshihisa Kinoshita, MD +81-532-37-3377 Ykinoshita@heart-center.or.jp | |
| Principal Investigator: Yoshihisa Kinoshita, MD | |
| Saiseikai Yokohama Eastern Hospital | Recruiting |
| Yokohama, Japan | |
| Contact: Masahiro Yamawaki, MD, PhD m_yamawaki@tobu.saiseikai.or.jp | |
| Principal Investigator: Masahiro Yamawaki, MD, PhD | |
| New Yukuhashi hospital | Recruiting |
| Yukuhashi, Japan, 824-0026 | |
| Contact: Yoshinobu Murasato, MD, PhD +81-930-24-8899 murasato@shinyukuhashihospital.or.jp | |
| Principal Investigator: Yoshinobu Murasato, MD, PhD | |
Sponsors and Collaborators
Shin Yukuhashi Hospital
Abbott Vascular
Cordis Corporation
Investigators
| Principal Investigator: | Yoshinobu Murasato, MD, PhD | New Yukuhashi Hospital |
| Principal Investigator: | Yoshihisa Kinoshita, MD | Toyohashi Heart Center |
More Information
No publications provided
| Responsible Party: | Yoshinobu Murasato, New Yukuhashi Hospital |
| ClinicalTrials.gov Identifier: | NCT01266239 History of Changes |
| Other Study ID Numbers: | J-REVERSE |
| Study First Received: | December 22, 2010 |
| Last Updated: | December 23, 2010 |
| Health Authority: | Japan: Institutional Review Board |
Keywords provided by Shin Yukuhashi Hospital:
|
Bifurcation lesion, drug-eluting stent, symmetric expansion |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Heart Diseases Coronary Disease Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Sirolimus Everolimus |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013