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Nobori And Uncoated Stent In Coronary Attack

Primary Purpose

Acute Myocardial Infarction

Status
Terminated
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Biolimus A9 eluting stents
uncoated stent
Sponsored by
Shigeru Saito
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring acute myocardial infarction, stents, angioplasty, thrombosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shonan Atsugi Hospital
  • Shonan Kamakura General Hospital
  • Tokyo nishi tokusyukai hospital
  • Shonan Atsugi hospital
  • Tokai University Hachioji Hospital
  • Hakodate Municipal Hospital
  • Hiratsuka kyosai hospital
  • Tokai University Hospital
  • Ishikawa Prefectural Central Hospital
  • Kanazawa Cardiovascular Hospital
  • Kasukabe chuo general Hospital
  • St.Marianna University School of Medicine Hospital
  • Chikamori Hospital
  • Komaki Municipal Hospital
  • Saitama Tobu Junkanki Hospital
  • Kurashiki Sentral Hospital
  • Kyoto Katsura Hospital
  • Hayama Heart Center
  • Omuta Tenryo Hospital
  • Osaki citizen hospital
  • Toshiba Rinkan Hospital
  • Saga Medical University Hospital
  • Saga-ken Medical Center Koseikan
  • Hokkaido Syakaihoken Hospital
  • Sapporo Hogashi Tokusyukai Hospital
  • Sapporo Tokusyukai Hospital
  • Sasebo Chuo hospital
  • Tosei General Hospital
  • Jichi Medical University Hospital
  • Sakurakai Takahashi Hospital
  • Taoka Hospital
  • Tokushima medical university hospital
  • Imus Katsushika Heart Center
  • Showa University Fujigaoka Hospital
  • Showa University Hospital
  • The Cardiovascular Institute
  • Toho University Hospital
  • Toho university ohashi medical center
  • Tokyo Medical and Dental Universtity Hospital
  • Tokyo medical University hospital
  • Toyama Prefectural Central Hospital
  • Izumikawa Hospital
  • Urazoe general hospital
  • Shonai Amarume Hospital
  • Saiseikai Yamaguchi General Hospital
  • Yamato Seiwa Hospital
  • Yao General Hospital
  • Kanagawa Cardiovascular and Respiratory Center
  • Saiseikai Yokohama Tobu Hospital
  • Yokohama Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Nobori

Uncoated stents

Arm Description

subjects receiving Biolimus A9 eluting stent implantation

subjects receiving uncoated stent implantation

Outcomes

Primary Outcome Measures

major adverse cardiac and cerebrovascular events (MACE)
MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization

Secondary Outcome Measures

major adverse cardiac and cerebrovascular events (MACE)
MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
stent thrombosis
target lesion revascularization

Full Information

First Posted
July 20, 2011
Last Updated
August 23, 2018
Sponsor
Shigeru Saito
Collaborators
NPO International TRI Network
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1. Study Identification

Unique Protocol Identification Number
NCT01401036
Brief Title
Nobori And Uncoated Stent In Coronary Attack
Official Title
Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Insufficient data collection
Study Start Date
July 2011 (Actual)
Primary Completion Date
August 5, 2015 (Actual)
Study Completion Date
December 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shigeru Saito
Collaborators
NPO International TRI Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
acute myocardial infarction, stents, angioplasty, thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1537 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nobori
Arm Type
Active Comparator
Arm Description
subjects receiving Biolimus A9 eluting stent implantation
Arm Title
Uncoated stents
Arm Type
Sham Comparator
Arm Description
subjects receiving uncoated stent implantation
Intervention Type
Device
Intervention Name(s)
Biolimus A9 eluting stents
Other Intervention Name(s)
Nobori® Drug Eluting Stent made by Terumo Corporation
Intervention Description
implantation of Biolimus A9 eluting stents
Intervention Type
Procedure
Intervention Name(s)
uncoated stent
Intervention Description
implantation of any uncoated bare metal stents currently available in Japan
Primary Outcome Measure Information:
Title
major adverse cardiac and cerebrovascular events (MACE)
Description
MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
major adverse cardiac and cerebrovascular events (MACE)
Description
MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
Time Frame
1 week
Title
stent thrombosis
Time Frame
1 week and 1 year
Title
target lesion revascularization
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeru Saito, MD
Organizational Affiliation
NPO International TRI Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shonan Atsugi Hospital
City
Atsugi
State/Province
Kanagawa
ZIP/Postal Code
243-0033
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
Tokyo nishi tokusyukai hospital
City
Akishima
Country
Japan
Facility Name
Shonan Atsugi hospital
City
Atsugi
Country
Japan
Facility Name
Tokai University Hachioji Hospital
City
Hachioji
Country
Japan
Facility Name
Hakodate Municipal Hospital
City
Hakodate
Country
Japan
Facility Name
Hiratsuka kyosai hospital
City
Hiratsuka
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Ishikawa
Country
Japan
Facility Name
Kanazawa Cardiovascular Hospital
City
Kanazawa
Country
Japan
Facility Name
Kasukabe chuo general Hospital
City
Kasukabe
Country
Japan
Facility Name
St.Marianna University School of Medicine Hospital
City
Kawasaki
Country
Japan
Facility Name
Chikamori Hospital
City
Kochi
Country
Japan
Facility Name
Komaki Municipal Hospital
City
Komaki
Country
Japan
Facility Name
Saitama Tobu Junkanki Hospital
City
Koshigoe
Country
Japan
Facility Name
Kurashiki Sentral Hospital
City
Kurashiki
Country
Japan
Facility Name
Kyoto Katsura Hospital
City
Kyoto
Country
Japan
Facility Name
Hayama Heart Center
City
Miura
Country
Japan
Facility Name
Omuta Tenryo Hospital
City
Omuta
Country
Japan
Facility Name
Osaki citizen hospital
City
Osaki
Country
Japan
Facility Name
Toshiba Rinkan Hospital
City
Sagamihara
Country
Japan
Facility Name
Saga Medical University Hospital
City
Saga
Country
Japan
Facility Name
Saga-ken Medical Center Koseikan
City
Saga
Country
Japan
Facility Name
Hokkaido Syakaihoken Hospital
City
Sapporo
Country
Japan
Facility Name
Sapporo Hogashi Tokusyukai Hospital
City
Sapporo
Country
Japan
Facility Name
Sapporo Tokusyukai Hospital
City
Sapporo
Country
Japan
Facility Name
Sasebo Chuo hospital
City
Sasebo
Country
Japan
Facility Name
Tosei General Hospital
City
Seto
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
Country
Japan
Facility Name
Sakurakai Takahashi Hospital
City
Suma
Country
Japan
Facility Name
Taoka Hospital
City
Tokushima
Country
Japan
Facility Name
Tokushima medical university hospital
City
Tokushima
Country
Japan
Facility Name
Imus Katsushika Heart Center
City
Tokyo
Country
Japan
Facility Name
Showa University Fujigaoka Hospital
City
Tokyo
Country
Japan
Facility Name
Showa University Hospital
City
Tokyo
Country
Japan
Facility Name
The Cardiovascular Institute
City
Tokyo
Country
Japan
Facility Name
Toho University Hospital
City
Tokyo
Country
Japan
Facility Name
Toho university ohashi medical center
City
Tokyo
Country
Japan
Facility Name
Tokyo Medical and Dental Universtity Hospital
City
Tokyo
Country
Japan
Facility Name
Tokyo medical University hospital
City
Tokyo
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
Country
Japan
Facility Name
Izumikawa Hospital
City
Unzen
Country
Japan
Facility Name
Urazoe general hospital
City
Urazoe
Country
Japan
Facility Name
Shonai Amarume Hospital
City
Yamagata
ZIP/Postal Code
9997782
Country
Japan
Facility Name
Saiseikai Yamaguchi General Hospital
City
Yamaguchi
Country
Japan
Facility Name
Yamato Seiwa Hospital
City
Yamato
Country
Japan
Facility Name
Yao General Hospital
City
Yao
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Yokohama
Country
Japan
Facility Name
Saiseikai Yokohama Tobu Hospital
City
Yokohama
Country
Japan
Facility Name
Yokohama Medical University Hospital
City
Yokohama
Country
Japan

12. IPD Sharing Statement

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Nobori And Uncoated Stent In Coronary Attack

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