Nobori And Uncoated Stent In Coronary Attack

Shigeru Saito

Status

Terminated

Conditions

Acute Myocardial Infarction

Treatments

Procedure: uncoated stent

Device: Biolimus A9 eluting stents

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01401036

20110629

Details and patient eligibility

About

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.

Enrollment

1,537 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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