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

Not Applicable

Completed

Conditions: Coronary Artery Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Myocardial Ischemia

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Drug Eluting Stent	MDT-4107 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.

Primary Outcome Measures

Name	Time	Method
In-stent Late Lumen Loss (LLL)	Post procedure, 8 Months	The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD

Secondary Outcome Measures

Name	Time	Method
Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)	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.
Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)	8 months
Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis	12 months

Locations (14): Yokohama Tobu Hospital
🇯🇵
Kanagawa, Japan
Shonan Kamakura General Hospital
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Kanagawa, Japan
Kumamoto Rosai Hospital
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Kumamoto, Japan
Jichi Medical University Hospital
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Tochigi, Japan
The Cardiovascular Institute Hospital
🇯🇵
Tokyo, Japan
Showa University Hospita
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Tokyo, Japan
Toho University Medical Center, Ohashi Hospital
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Tokyo, Japan
Toyohashi Heart Center
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Aichi, Japan
Hospital Hakodate Hokkaido
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Hokkaido, Japan
Kansai Rosai Hospital
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Hyogo, Japan
Kanto Rosai Hospital
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Kanagawa, Japan
Kyoto Katsura Hospital
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Kyoto, Japan
Kurashiki Central Hospital
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Okayama, Japan
Teikyo University Hospital
🇯🇵
Tokyo, Japan