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

This study is ongoing, but not recruiting participants.
Medtronic Japan Co., Ltd.
Information provided by (Responsible Party):
Medtronic Vascular Identifier:
First received: June 23, 2009
Last updated: December 2, 2013
Last verified: December 2013

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 Intervention
Arterial Occlusive Diseases
Myocardial Ischemia
Cardiovascular Diseases
Coronary Artery Disease
Device: MDT-4107 Drug Eluting Stent

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Medtronic Vascular:

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

Secondary Outcome Measures:
  • Percent of Patient With Target Lesion Failure(Major Secondary Endpoint) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO) [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00927940

Toyohashi Heart Center
Aichi, Japan, 441-8530
Hospital Hakodate Hokkaido
Hokkaido, Japan, 041-8680
Kansai Rosai Hospital
Hyogo, Japan, 660-8511
Shonan Kamakura General Hospital
Kanagawa, Japan, 247-8533
Yokohama Tobu Hospital
Kanagawa, Japan, 230-0012
Kanto Rosai Hospital
Kanagawa, Japan, 211-8510
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
Toho University Medical Center, Ohashi Hospital
Tokyo, Japan, 153-6181
Teikyo University Hospital
Tokyo, Japan, 173-8606
Showa University Hospita
Tokyo, Japan, 142-8666
The Cardiovascular Institute Hospital
Tokyo, Japan, 106-0032
Sponsors and Collaborators
Medtronic Vascular
Medtronic Japan Co., Ltd.
Principal Investigator: Shigeru Saito, MD Shonan Kamakura General Hospital
  More Information

Additional Information:
No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Vascular Identifier: NCT00927940     History of Changes
Other Study ID Numbers: MDT2-07-03
Study First Received: June 23, 2009
Results First Received: February 9, 2012
Last Updated: December 2, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Medtronic Vascular:

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Vascular Diseases
Heart Diseases
Pathologic Processes processed this record on April 14, 2014