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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004138
Receipt No. R000004970
Scientific Title Clinical safety evaluation of Endeavor stent in octogenerians.
Date of disclosure of the study information 2010/09/01
Last modified on 2010/08/31

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Basic information
Public title Clinical safety evaluation of Endeavor stent in octogenerians.
Acronym E-OCTO Registry
Scientific Title Clinical safety evaluation of Endeavor stent in octogenerians.
Scientific Title:Acronym E-OCTO Registry
Region
Japan

Condition
Condition Coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the occurence of clinical events and bleeding complications with Endeavor stent in octogenerians.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MACCE (Death, myocardial infarction, cerebrovascular accident, target lesion revascularization, target vessel revascularization)
Key secondary outcomes The occurence of bleeding complications, stent thrombosis, the duration of dual antiplatelet agents.

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
80 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients is over 80 years old.
2)Patient has clinical evidence of ischemic heart disease and/or a positive functional study.
3)Patients is an acceptable candidate for percutaneous coronary intervention and stenting.
4)Patients has been informed of the nature of the trial before procedure and agrees to its provisions and has been provided written informed consent as approved by the Institutional Review Board(IRB) or equal one of the respective investigational site. Or post procedual agreement is acceptable only if its approved by the IRB.
Key exclusion criteria 1)Limited Life expectancy within 12months.
2)Inability to comply with the required IFU antiplatelet regimen.
3)Ejection Fraction<30%.
4)Unprotected LMT disease.
5)Chronic Total Occulution.
6)The lesions in all native coronary arteries, LCX/LAD/RCA should be amenable to PCI.
7)Severe valvular disease.
8)Renal Failure.
9)Taking Warfarin Potassium.
10)Planed PCI of any vessel within 30 days post-index procedure and/or planed PCI of the target vessel(s) within 12 months post-procedure.
11)Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel and ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coating (e.g.PC polymer) or a sensitivity to contrast media, which cannot be adequately pre-medicated.
12)Acute myocardial infaction with cardogenic shock.
13)Previous stenting in the target vessel(s).
14)Prior to enrollment in this study, if a surgical or any procedure is anticipated that would require early discontinuation of 3-month antiplatelet therapy.
15)Patient is not an acceptable candidate for PCI at a physician's discretion.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Koyama
Organization Shinkawabashi hospital
Division name Cardiovascular center
Zip code
Address 1-15 Shinkawabashi, Kawasaki-ku, Kawasaki, Kanagawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shinkawabashi hospital
Division name The office of E-OCTO Registry
Zip code
Address
TEL
Homepage URL
Email cvcenter@shinkawabashi.or.jp

Sponsor
Institute Cardiovascular center, Shinkawabashi hospital
Institute
Department

Funding Source
Organization Medtronic Japan Co.,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2010 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2010 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the safety and efficacy of Endeavor stent in octogenerians prospectively. Especially to observe the occurance of clinical events and bleeding complications in the case of cessation of dual antiplatelet agents in 3 months.

Management information
Registered date
2010 Year 08 Month 31 Day
Last modified on
2010 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004970

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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