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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000149
Receipt No. R000000215
Scientific Title Effect of local delivery of Evans blue on prevention of restenosis after coronary stenting
Date of disclosure of the study information 2005/09/13
Last modified on 2005/09/09

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Basic information
Public title Effect of local delivery of Evans blue on prevention of restenosis after coronary stenting
Acronym Effect of local delivery of Evans blue on prevention of restenosis after coronary stenting
Scientific Title Effect of local delivery of Evans blue on prevention of restenosis after coronary stenting
Scientific Title:Acronym Effect of local delivery of Evans blue on prevention of restenosis after coronary stenting
Region
Japan

Condition
Condition Angina pectoris, myocardial infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether local delivery of Evans blue can prevent restenosis after coronary stenting, and its' safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate diameter stenosis and restenosis rate on follow up coronary angiogram 6 month after stenting.
Key secondary outcomes To evaluate the side effects and complications of local delivery of Evans blue.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Evans blue group: we locally administer 1cc of 2% Evans blue solution on stenting site, 3 weeks after stenting in patients with acute myocardial infarction, and immediately after stenting in patients with angina pectoris. Control group: usual stenting, without local delivery of Evans blue.
Interventions/Control_2 Control group
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with angina pectoris who
undergo stent placement, and with acute myocardial infarction who undergo primary stent.
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiharu Fujimori
Organization Narita Red Cross Hospital
Division name Department of Cardiology
Zip code
Address 90-1, Iida-cho, Narita, Chiba
TEL 0476-22-2311
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiharu Fujimori
Organization Narita Red Cross Hospital
Division name Department of Cardiology
Zip code
Address 90-1, Iida-cho, Narita, Chiba
TEL 0476-22-2311
Homepage URL
Email fm@naritasekijyuji.jp

Sponsor
Institute Narita Red Cross Hospital,
Department of Cardiology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2005 Year 09 Month 13 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 No longer recruiting
Date of protocol fixation
2000 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2000 Year 01 Month 01 Day
Last follow-up date
2005 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 09 Day
Last modified on
2005 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000215

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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