Nobori And Uncoated Stent In Coronary Attack

August 23, 2018 updated by: Shigeru Saito

Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1537

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Akishima, Japan
        • Tokyo nishi tokusyukai hospital
      • Atsugi, Japan
        • Shonan Atsugi Hospital
      • Hachioji, Japan
        • Tokai University Hachioji Hospital
      • Hakodate, Japan
        • Hakodate Municipal Hospital
      • Hiratsuka, Japan
        • Hiratsuka Kyosai Hospital
      • Isehara, Japan
        • Tokai University Hospital
      • Ishikawa, Japan
        • Ishikawa Prefectural Central Hospital
      • Kanazawa, Japan
        • Kanazawa Cardiovascular Hospital
      • Kasukabe, Japan
        • Kasukabe Chuo General Hospital
      • Kawasaki, Japan
        • St.Marianna University School of Medicine hospital
      • Kochi, Japan
        • Chikamori Hospital
      • Komaki, Japan
        • Komaki Municipal Hospital
      • Koshigoe, Japan
        • Saitama Tobu Junkanki Hospital
      • Kurashiki, Japan
        • Kurashiki Sentral Hospital
      • Kyoto, Japan
        • Kyoto Katsura Hospital
      • Miura, Japan
        • Hayama Heart Center
      • Omuta, Japan
        • Omuta Tenryo Hospital
      • Osaki, Japan
        • Osaki Citizen Hospital
      • Saga, Japan
        • Saga Medical University Hospital
      • Saga, Japan
        • Saga-Ken Medical Center Koseikan
      • Sagamihara, Japan
        • Toshiba Rinkan Hospital
      • Sapporo, Japan
        • Hokkaido Syakaihoken Hospital
      • Sapporo, Japan
        • Sapporo Hogashi Tokusyukai Hospital
      • Sapporo, Japan
        • Sapporo Tokusyukai Hospital
      • Sasebo, Japan
        • Sasebo Chuo Hospital
      • Seto, Japan
        • Tosei General Hospital
      • Shimotsuke, Japan
        • Jichi Medical University Hospital
      • Suma, Japan
        • Sakurakai Takahashi Hospital
      • Tokushima, Japan
        • Taoka Hospital
      • Tokushima, Japan
        • Tokushima medical university hospital
      • Tokyo, Japan
        • Toho University Ohashi Medical Center
      • Tokyo, Japan
        • Showa University Hospital
      • Tokyo, Japan
        • Tokyo Medical University Hospital
      • Tokyo, Japan
        • Imus Katsushika Heart Center
      • Tokyo, Japan
        • Showa University Fujigaoka Hospital
      • Tokyo, Japan
        • The Cardiovascular Institute
      • Tokyo, Japan
        • Toho University Hospital
      • Tokyo, Japan
        • Tokyo Medical and Dental Universtity Hospital
      • Toyama, Japan
        • Toyama Prefectural Central Hospital
      • Unzen, Japan
        • Izumikawa Hospital
      • Urazoe, Japan
        • Urazoe general hospital
      • Yamagata, Japan, 9997782
        • Shonai Amarume Hospital
      • Yamaguchi, Japan
        • Saiseikai Yamaguchi General Hospital
      • Yamato, Japan
        • Yamato Seiwa Hospital
      • Yao, Japan
        • Yao General Hospital
      • Yokohama, Japan
        • Kanagawa Cardiovascular and Respiratory Center
      • Yokohama, Japan
        • Saiseikai Yokohama tobu Hospital
      • Yokohama, Japan
        • Yokohama Medical University Hospital
    • Kanagawa
      • Atsugi, Kanagawa, Japan, 243-0033
        • Shonan Atsugi Hospital
      • Kamakura, Kanagawa, Japan, 247-8533
        • Shonan Kamakura General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Nobori
subjects receiving Biolimus A9 eluting stent implantation
Device: Biolimus A9 eluting stents
implantation of Biolimus A9 eluting stents
Other Names:
  • Nobori® Drug Eluting Stent made by Terumo Corporation
SHAM_COMPARATOR: Uncoated stents
subjects receiving uncoated stent implantation
Procedure: uncoated stent
implantation of any uncoated bare metal stents currently available in Japan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shigeru Saito

Collaborators

NPO International TRI Network

Investigators

  • Principal Investigator: Shigeru Saito, MD, NPO International TRI Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2011

Primary Completion (ACTUAL)

August 5, 2015

Study Completion (ACTUAL)

December 7, 2017

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

July 22, 2011

First Posted (ESTIMATE)

July 25, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110629

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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