Nobori And Uncoated Stent In Coronary Attack

Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01401036

Enrollment

1537

Registered

2011-07-25

Start date

2011-07-31

Completion date

2017-12-07

Last updated

2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

acute myocardial infarction, stents, angioplasty, thrombosis

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.

Interventions

DEVICEBiolimus A9 eluting stents

implantation of Biolimus A9 eluting stents

PROCEDUREuncoated stent

implantation of any uncoated bare metal stents currently available in Japan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
major adverse cardiac and cerebrovascular events (MACE)	1 year	MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization

Secondary

Measure	Time frame	Description
major adverse cardiac and cerebrovascular events (MACE)	1 week	MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
stent thrombosis	1 week and 1 year	—
target lesion revascularization	1 year	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026