UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004138 |
|---|---|
| Receipt number | 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 17:29:39 |
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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
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
cvcenter@shinkawabashi.or.jp
Sponsor or person
Institute
Cardiovascular center, Shinkawabashi hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004970
