Nobori And Uncoated Stent In Coronary Attack
- Conditions
- Acute Myocardial Infarction
- Interventions
- Device: Biolimus A9 eluting stentsProcedure: uncoated stent
- Registration Number
- NCT01401036
- Lead Sponsor
- Shigeru Saito
- Brief Summary
Drug-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of Nobori (Biolimus A9 Eluting Stent) in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). Accordingly, the investigators will compare the outcomes of primary PCI for AMI between patients receiving Nobori versus uncoated stents.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1537
- age more than 20 years old
- 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
- previous stent implantation within 30 days
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nobori Biolimus A9 eluting stents subjects receiving Biolimus A9 eluting stent implantation Uncoated stents uncoated stent subjects receiving uncoated stent implantation
- Primary Outcome Measures
Name Time Method major adverse cardiac and cerebrovascular events (MACE) 1 year MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
- Secondary Outcome Measures
Name Time Method major adverse cardiac and cerebrovascular events (MACE) 1 week MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
target lesion revascularization 1 year stent thrombosis 1 week and 1 year
Trial Locations
- Locations (50)
Kurashiki Sentral Hospital
🇯🇵Kurashiki, Japan
Osaki citizen hospital
🇯🇵Osaki, Japan
Toshiba Rinkan Hospital
🇯🇵Sagamihara, Japan
Saga-ken Medical Center Koseikan
🇯🇵Saga, Japan
Sasebo Chuo hospital
🇯🇵Sasebo, Japan
Tosei General Hospital
🇯🇵Seto, Japan
Sakurakai Takahashi Hospital
🇯🇵Suma, Japan
Taoka Hospital
🇯🇵Tokushima, Japan
Tokushima medical university hospital
🇯🇵Tokushima, Japan
Showa University Hospital
🇯🇵Tokyo, Japan
Toho University Hospital
🇯🇵Tokyo, Japan
Toho university ohashi medical center
🇯🇵Tokyo, Japan
Tokyo medical University hospital
🇯🇵Tokyo, Japan
Urazoe general hospital
🇯🇵Urazoe, Japan
Shonai Amarume Hospital
🇯🇵Yamagata, Japan
Izumikawa Hospital
🇯🇵Unzen, Japan
Yao General Hospital
🇯🇵Yao, Japan
Saiseikai Yokohama Tobu Hospital
🇯🇵Yokohama, Japan
Shonan Atsugi Hospital
🇯🇵Atsugi, Kanagawa, Japan
Shonan Kamakura General Hospital
🇯🇵Kamakura, Kanagawa, Japan
Hiratsuka kyosai hospital
🇯🇵Hiratsuka, Japan
Tokyo nishi tokusyukai hospital
🇯🇵Akishima, Japan
Hayama Heart Center
🇯🇵Miura, Japan
Shonan Atsugi hospital
🇯🇵Atsugi, Japan
Tokai University Hachioji Hospital
🇯🇵Hachioji, Japan
Hakodate Municipal Hospital
🇯🇵Hakodate, Japan
Tokai University Hospital
🇯🇵Isehara, Japan
Kasukabe chuo general Hospital
🇯🇵Kasukabe, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Ishikawa, Japan
Kanazawa Cardiovascular Hospital
🇯🇵Kanazawa, Japan
St.Marianna University School of Medicine Hospital
🇯🇵Kawasaki, Japan
Chikamori Hospital
🇯🇵Kochi, Japan
Saitama Tobu Junkanki Hospital
🇯🇵Koshigoe, Japan
Kyoto Katsura Hospital
🇯🇵Kyoto, Japan
Komaki Municipal Hospital
🇯🇵Komaki, Japan
Omuta Tenryo Hospital
🇯🇵Omuta, Japan
Saga Medical University Hospital
🇯🇵Saga, Japan
Imus Katsushika Heart Center
🇯🇵Tokyo, Japan
Hokkaido Syakaihoken Hospital
🇯🇵Sapporo, Japan
Sapporo Hogashi Tokusyukai Hospital
🇯🇵Sapporo, Japan
Sapporo Tokusyukai Hospital
🇯🇵Sapporo, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Japan
Showa University Fujigaoka Hospital
🇯🇵Tokyo, Japan
The Cardiovascular Institute
🇯🇵Tokyo, Japan
Tokyo Medical and Dental Universtity Hospital
🇯🇵Tokyo, Japan
Saiseikai Yamaguchi General Hospital
🇯🇵Yamaguchi, Japan
Kanagawa Cardiovascular and Respiratory Center
🇯🇵Yokohama, Japan
Yokohama Medical University Hospital
🇯🇵Yokohama, Japan
Toyama Prefectural Central Hospital
🇯🇵Toyama, Japan
Yamato Seiwa Hospital
🇯🇵Yamato, Japan