Status:
TERMINATED
Nobori And Uncoated Stent In Coronary Attack
Lead Sponsor:
Shigeru Saito
Collaborating Sponsors:
NPO International TRI Network
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
20+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2017
Estimated Enrollment :
1537 Patients enrolled
Trial Details
Trial ID
NCT01401036
Start Date
July 1 2011
End Date
December 7 2017
Last Update
August 27 2018
Active Locations (50)
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1
Shonan Atsugi Hospital
Atsugi, Kanagawa, Japan, 243-0033
2
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan, 247-8533
3
Tokyo nishi tokusyukai hospital
Akishima, Japan
4
Shonan Atsugi hospital
Atsugi, Japan