Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1537 participants
INTERVENTIONAL
2011-07-31
2017-12-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nobori
subjects receiving Biolimus A9 eluting stent implantation
Biolimus A9 eluting stents
implantation of Biolimus A9 eluting stents
Uncoated stents
subjects receiving uncoated stent implantation
uncoated stent
implantation of any uncoated bare metal stents currently available in Japan
Interventions
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Biolimus A9 eluting stents
implantation of Biolimus A9 eluting stents
uncoated stent
implantation of any uncoated bare metal stents currently available in Japan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* chest pain lasting more than 20 min
* symptoms beginning within 12 hours before characterization
* electrocardiogram showing ST-segment elevation or new appearance of left bundle branch block
* increase in cardiac enzymes to more than 5-fold the normal laboratory values
* infarct-related vessel are anatomically suitable for percutaneous revascularization
* patients gave their signed, informed consent
Exclusion Criteria
* allergy to any of the followings : aspirin, heparin, clopidogrel, biolimus A9 or its derivatives, stainless steel 316L, PLA (Poly-Lactic Acid) Polymer or its derivatives, and contrast media
* elective surgery scheduled within 6 months
* renal insufficiency with creatinine level of more than 2.5 mg/dL
* patients associated with bleeding and/or clotting disorders, and those refusing blood transfusion
* history of massive gastrointestinal or urinary tract bleeding within 6 months
* patients currently enrolled in other clinical trials
* pregnancy
20 Years
ALL
No
Sponsors
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NPO International TRI Network
NETWORK
Shigeru Saito
NETWORK
Responsible Party
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Shigeru Saito
Director, Cardiology, Shonan Kamakura General Hospital
Principal Investigators
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Shigeru Saito, MD
Role: PRINCIPAL_INVESTIGATOR
NPO International TRI Network
Locations
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Shonan Atsugi Hospital
Atsugi, Kanagawa, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Tokyo nishi tokusyukai hospital
Akishima, , Japan
Shonan Atsugi hospital
Atsugi, , Japan
Tokai University Hachioji Hospital
Hachiōji, , Japan
Hakodate Municipal Hospital
Hakodate, , Japan
Hiratsuka kyosai hospital
Hiratsuka, , Japan
Tokai University Hospital
Isehara, , Japan
Ishikawa Prefectural Central Hospital
Ishikawa, , Japan
Kanazawa Cardiovascular Hospital
Kanazawa, , Japan
Kasukabe chuo general Hospital
Kasukabe, , Japan
St.Marianna University School of Medicine Hospital
Kawasaki, , Japan
Chikamori Hospital
Kochi, , Japan
Komaki Municipal Hospital
Komaki, , Japan
Saitama Tobu Junkanki Hospital
Koshigoe, , Japan
Kurashiki Sentral Hospital
Kurashiki, , Japan
Kyoto Katsura Hospital
Kyoto, , Japan
Hayama Heart Center
Miura, , Japan
Omuta Tenryo Hospital
Omuta, , Japan
Osaki citizen hospital
Ōsaki, , Japan
Saga Medical University Hospital
Saga, , Japan
Saga-ken Medical Center Koseikan
Saga, , Japan
Toshiba Rinkan Hospital
Sagamihara, , Japan
Hokkaido Syakaihoken Hospital
Sapporo, , Japan
Sapporo Hogashi Tokusyukai Hospital
Sapporo, , Japan
Sapporo Tokusyukai Hospital
Sapporo, , Japan
Sasebo Chuo hospital
Sasebo, , Japan
Tosei General Hospital
Seto, , Japan
Jichi Medical University Hospital
Shimotsuke, , Japan
Sakurakai Takahashi Hospital
Suma, , Japan
Taoka Hospital
Tokushima, , Japan
Tokushima medical university hospital
Tokushima, , Japan
Imus Katsushika Heart Center
Tokyo, , Japan
Showa University Fujigaoka Hospital
Tokyo, , Japan
Showa University Hospital
Tokyo, , Japan
The Cardiovascular Institute
Tokyo, , Japan
Toho University Hospital
Tokyo, , Japan
Toho university ohashi medical center
Tokyo, , Japan
Tokyo Medical and Dental Universtity Hospital
Tokyo, , Japan
Tokyo medical University hospital
Tokyo, , Japan
Toyama Prefectural Central Hospital
Toyama, , Japan
Izumikawa Hospital
Unzen, , Japan
Urazoe general hospital
Urazoe, , Japan
Shonai Amarume Hospital
Yamagata, , Japan
Saiseikai Yamaguchi General Hospital
Yamaguchi, , Japan
Yamato Seiwa Hospital
Yamato, , Japan
Yao General Hospital
Yao, , Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, , Japan
Saiseikai Yokohama Tobu Hospital
Yokohama, , Japan
Yokohama Medical University Hospital
Yokohama, , Japan
Countries
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Other Identifiers
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20110629
Identifier Type: -
Identifier Source: org_study_id
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