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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Toyohashi Heart Center
Aichi, Japan
Hospital Hakodate Hokkaido
Hokkaido, Japan
Kansai Rosai Hospital
Hyōgo, Japan
In-stent Late Lumen Loss (LLL)
The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD
Time frame: Post procedure, 8 Months
Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)
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.
Time frame: 12 months
Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis
Time frame: 12 months
Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)
Time frame: 8 months
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Kanto Rosai Hospital
Kanagawa, Japan
Yokohama Tobu Hospital
Kanagawa, Japan
Shonan Kamakura General Hospital
Kanagawa, Japan
Kumamoto Rosai Hospital
Kumamoto, Japan
Kyoto Katsura Hospital
Kyoto, Japan
Kurashiki Central Hospital
Okayama, Japan
Jichi Medical University Hospital
Tochigi, Japan
...and 4 more locations