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RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent (RJ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00927940
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : July 9, 2012
Last Update Posted : May 5, 2015
Medtronic Japan Co., Ltd.
Information provided by (Responsible Party):
Medtronic Vascular

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.

Condition or disease Intervention/treatment Phase
Arterial Occlusive Diseases Myocardial Ischemia Cardiovascular Diseases Coronary Artery Disease Device: MDT-4107 Drug Eluting Stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries
Study Start Date : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Drug Eluting Stent
All 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.
Device: MDT-4107 Drug Eluting Stent
Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Other Name: Zotarolimus Eluting Coronary Stent

Primary Outcome Measures :
  1. In-stent Late Lumen Loss (LLL) [ Time Frame: Post procedure, 8 Months ]
    The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD

Secondary Outcome Measures :
  1. Percent of Patient With Target Lesion Failure(Major Secondary Endpoint) [ Time Frame: 12 months ]
    Major Secondary Endpoint Target lesion fature (TLF) is defined as cardiac death, target vessel myocardial infarction(Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.

  2. Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis [ Time Frame: 12 months ]
  3. Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO) [ Time Frame: 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00927940

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Toyohashi Heart Center
Aichi, Japan, 441-8530
Hospital Hakodate Hokkaido
Hokkaido, Japan, 041-8680
Kansai Rosai Hospital
Hyogo, Japan, 660-8511
Kanto Rosai Hospital
Kanagawa, Japan, 211-8510
Yokohama Tobu Hospital
Kanagawa, Japan, 230-0012
Shonan Kamakura General Hospital
Kanagawa, Japan, 247-8533
Kumamoto Rosai Hospital
Kumamoto, Japan, 866-8533
Kyoto Katsura Hospital
Kyoto, Japan, 615-8256
Kurashiki Central Hospital
Okayama, Japan, 710-8602
Jichi Medical University Hospital
Tochigi, Japan, 329-0498
The Cardiovascular Institute Hospital
Tokyo, Japan, 106-0032
Showa University Hospita
Tokyo, Japan, 142-8666
Toho University Medical Center, Ohashi Hospital
Tokyo, Japan, 153-6181
Teikyo University Hospital
Tokyo, Japan, 173-8606
Sponsors and Collaborators
Medtronic Vascular
Medtronic Japan Co., Ltd.
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Principal Investigator: Shigeru Saito, MD Shonan Kamakura General Hospital
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Medtronic Vascular Identifier: NCT00927940    
Other Study ID Numbers: MDT2-07-03
First Posted: June 25, 2009    Key Record Dates
Results First Posted: July 9, 2012
Last Update Posted: May 5, 2015
Last Verified: April 2015
Keywords provided by Medtronic Vascular:
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Vascular Diseases
Pathologic Processes