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Clinical Trials/NCT01401036
NCT01401036
Terminated
Not Applicable

Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction

Shigeru Saito50 sites in 1 country1,537 target enrollmentJuly 2011
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ConditionsAcute Myocardial Infarction

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Myocardial Infarction
Sponsor
Shigeru Saito
Enrollment
1537
Locations
50
Primary Endpoint
major adverse cardiac and cerebrovascular events (MACE)
Status
Terminated
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
December 7, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shigeru Saito
Responsible Party
Sponsor Investigator
Principal Investigator

Shigeru Saito

Director, Cardiology, Shonan Kamakura General Hospital

NAUSICA Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

major adverse cardiac and cerebrovascular events (MACE)

Time Frame: 1 year

MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization

Secondary Outcomes

  • major adverse cardiac and cerebrovascular events (MACE)(1 week)
  • target lesion revascularization(1 year)
  • stent thrombosis(1 week and 1 year)

Study Sites (50)

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