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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008076
Receipt No. R000009511
Scientific Title Clinical Performance of the Endeavor Zotarolimus-Eluting Stent in Real-world Japanese Patients: A Prospective Multicenter Registry
Date of disclosure of the study information 2012/06/04
Last modified on 2013/12/06

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Basic information
Public title Clinical Performance of the Endeavor Zotarolimus-Eluting Stent in Real-world Japanese Patients: A Prospective Multicenter Registry
Acronym E-KANSAI Registry
Scientific Title Clinical Performance of the Endeavor Zotarolimus-Eluting Stent in Real-world Japanese Patients: A Prospective Multicenter Registry
Scientific Title:Acronym E-KANSAI Registry
Region
Japan

Condition
Condition Ischemic Heart Disease/Coronary Artery Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate the long-term efficacy and safety of the Endeavor stent system in the current clinical setting. Results from the study will be compared with those from the E-Five study, which is a large-scale registry study conducted in South America, Europe, Asia, and Oceania to reflect the actual clinical use of the device, for the purpose of comparing clinical data of the Endeavor stent system in Japan and overseas countries.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Incidence of major adverse cardiac events (MACE; defined as all-cause death, myocardial infarction, coronary artery bypass grafting, and target lesion revascularization [TLR]) at 12 months post-procedure.
Key secondary outcomes Incidence of subacute stent thrombosis between 0 and 30 days post-procedure, and incidence of late-onset stent thrombosis between 31 and 360 days post-procedure.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Age of 18 years or older.
2. Clinical symptoms of ischemic heart
disease, OR ischemia confirmed by
cardiac function tests.
3. Patients eligible for percutaneous
transluminal coronary angioplasty
(PTCA) and stent implant procedure.
4. Pre-procedure consent to the details
and conditions of the study after pre-
procedure explanation of the study,
in principle. Post-procedure patient
enrollment requires prior approval of
the joint ethical committee for the
method of post-procedure enrollment.
Key exclusion criteria 1. Women known to be pregant or
lactating mothers.
2. Known hypersensitivity or allergy to
drugs including aspirin, heparin,
clopidogrel, ticlopidine, and ABT-
578; rapamycin, tacrolimus,
sirolimus, or their analogues, or
other analogues/derivatives; or
cobalt, chrome, nickel, molybdenum,
or contrast media.
3. Life expectancy estimated to be less
than 12 months.
4. Acute myocardial infarction (AMI)
accompanied by cardiogenic shock.
5. Preexisting stents (drug-eluting
stents [DES] or bare metal stents
[BMS]) in the target vessel (stents
in a branch of the target vessel do
not preclude enrollment).
6. Patients known to have difficulty in
continuing dual antiplatelet therapy
(DAPT) because of a plan of other
surgery after stenting.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Otsuji
Organization Higashi Takarazuka Satoh Hospital
Division name Department of Cardiology
Zip code
Address 2-1 Nagao-cho,Takarazuka City, Hyogo, Japan
TEL +81.797.88.2200
Email aeei_trial@aeeijapan.org

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Otsuji
Organization Higashi Takarazuka Satoh Hospital
Division name Department of Cardiology
Zip code
Address 2-1 Nagao-cho,Takarazuka City, Hyogo, Japan
TEL +81.797.88.2200
Homepage URL
Email aeei_trial@aeeijapan.org

Sponsor
Institute Associations for Establishment of Evidence in Interventions
Institute
Department

Funding Source
Organization Associations for Establishment of Evidence in Interventions
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2013 Year 07 Month 01 Day
Date of closure to data entry
2013 Year 08 Month 01 Day
Date trial data considered complete
2013 Year 10 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information Site visit is not necessarily needed for survival confirmation, which can be done with other means, such as telephone and e-mail. However, if a patient reports any coronary intervention or diagnostic imaging performed after the last follow-up or complains of any ischemic symptoms or other symptoms suggesting ischemia, the patient should be encouraged to visit the site for necessary follow-up assessments.
Clinical follow-up will be conducted to assess clinical endpoints including the incidence of MACE. Site visits will be planned at 30 days, 6 to 8 months, and 12 months post-procedure. Each follow-up can be done via telephone or other means for survival confirmation and will not necessarily require site visit. However, if a subject reports that he or she had any coronary intervention or diagnostic tests and diagnostic imaging, or any ischemia-related symptoms, the subject must visit the site for follow-up assessments.

Management information
Registered date
2012 Year 06 Month 01 Day
Last modified on
2013 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009511

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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