RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent
RJ
The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries
1 other identifier
interventional
100
1 country
14
Brief Summary
The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent for the treatment of de novo lesions in native coronary arteries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2009
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 23, 2009
CompletedFirst Posted
Study publicly available on registry
June 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedResults Posted
Study results publicly available
July 9, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMay 5, 2015
April 1, 2015
1.8 years
June 23, 2009
February 9, 2012
April 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-stent Late Lumen Loss (LLL)
The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD
Post procedure, 8 Months
Secondary Outcomes (3)
Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)
12 months
Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis
12 months
Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)
8 months
Study Arms (1)
Drug Eluting Stent
EXPERIMENTALAll patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
Interventions
Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Eligibility Criteria
You may qualify if:
- Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
- Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
- Informed consent
- Patient agrees to comply with specified follow-up evaluations at same investigational site
- Single target lesion or two target lesions located in separate coronary arteries
- De novo lesion(s) in native coronary artery(ies)
- Target lesion(s) ≤ 27 mm in length
- Target vessel(s) have reference vessel diameter 2.5 mm to 3.5 mm
You may not qualify if:
- Within 7 days of implant platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; white blood cell (WBC) count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl
- Acute myocadial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI) or any elevation of Creatinine Kinase Mycocardial-band Isoemzyme (CK-MB) \> lab upper limit of normal)
- Previous PCI of target vessel(s) within 9 months prior to the procedure
- Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
- History of stroke or transient ischemic attack (TIA) within prior 6 months
- Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
- Inability to comply with required trial antiplatelet regimen
- Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
- Target vessel(s) has/have other lesions w/ \> 40% diameter stenosis
- Unprotected left main coronary artery disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Vascularlead
- Medtronic Japan Co., Ltd.collaborator
Study Sites (14)
Toyohashi Heart Center
Aichi, 441-8530, Japan
Hospital Hakodate Hokkaido
Hokkaido, 041-8680, Japan
Kansai Rosai Hospital
Hyōgo, 660-8511, Japan
Kanto Rosai Hospital
Kanagawa, 211-8510, Japan
Yokohama Tobu Hospital
Kanagawa, 230-0012, Japan
Shonan Kamakura General Hospital
Kanagawa, 247-8533, Japan
Kumamoto Rosai Hospital
Kumamoto, 866-8533, Japan
Kyoto Katsura Hospital
Kyoto, 615-8256, Japan
Kurashiki Central Hospital
Okayama, 710-8602, Japan
Jichi Medical University Hospital
Tochigi, 329-0498, Japan
The Cardiovascular Institute Hospital
Tokyo, 106-0032, Japan
Showa University Hospita
Tokyo, 142-8666, Japan
Toho University Medical Center, Ohashi Hospital
Tokyo, 153-6181, Japan
Teikyo University Hospital
Tokyo, 173-8606, Japan
Related Publications (4)
Saito S, Maehara A, Vlachojannis GJ, Parise H, Mehran R; RESOLUTE Japan Investigators. Clinical and angiographic evaluation of the resolute zotarolimus-eluting coronary stent in Japanese patients - long-term outcome in the RESOLUTE Japan and RESOLUTE Japan small vessel study. Circ J. 2015;79(1):96-103. doi: 10.1253/circj.CJ-14-0836. Epub 2014 Nov 27.
PMID: 25428602DERIVEDSilber S, Kirtane AJ, Belardi JA, Liu M, Brar S, Rothman M, Windecker S. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. 2014 Aug 1;35(29):1949-56. doi: 10.1093/eurheartj/ehu026. Epub 2014 Feb 7.
PMID: 24510638DERIVEDSilber S, Serruys PW, Leon MB, Meredith IT, Windecker S, Neumann FJ, Belardi J, Widimsky P, Massaro J, Novack V, Yeung AC, Saito S, Mauri L. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv. 2013 Apr;6(4):357-68. doi: 10.1016/j.jcin.2012.11.006. Epub 2013 Mar 20.
PMID: 23523454DERIVEDFarooq V, Vranckx P, Mauri L, Cutlip DE, Belardi J, Silber S, Widimsky P, Leon M, Windecker S, Meredith I, Negoita M, van Leeuwen F, Neumann FJ, Yeung AC, Garcia-Garcia HM, Serruys PW. Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program. Heart. 2013 May;99(9):626-33. doi: 10.1136/heartjnl-2012-303368. Epub 2013 Mar 6.
PMID: 23468513DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hiroko Okubo
- Organization
- Medtronic Japan Co.,Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
Shigeru Saito, MD
Shonan Kamakura General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2009
First Posted
June 25, 2009
Study Start
March 1, 2009
Primary Completion
December 1, 2010
Study Completion
February 1, 2015
Last Updated
May 5, 2015
Results First Posted
July 9, 2012
Record last verified: 2015-04