UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002038
Receipt No. R000002490
Scientific Title intra-arterial thrombolysis for acute cerebral major vessel occlusion with unknown onset
Date of disclosure of the study information 2009/06/04
Last modified on 2013/06/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title intra-arterial thrombolysis for acute cerebral major vessel occlusion with unknown onset
Acronym intra-arterial thrombolysis for acute cerebral major vessel occlusion with unknown onset
Scientific Title intra-arterial thrombolysis for acute cerebral major vessel occlusion with unknown onset
Scientific Title:Acronym intra-arterial thrombolysis for acute cerebral major vessel occlusion with unknown onset
Region
Japan

Condition
Condition acute cerebral major vessel occlusion
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The evaluation of safety and efficacy for intra-arterial thrombolytic therapy for acute cerebral major vessel occlusion with unknown onset
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes recanalization rate
hemorrhagic complication
outcome after 1 month
Key secondary outcomes other complications
outcome after 6 month

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 intra-arterial thrombolysis using urokinase or percutaneous transluminal angioplasty for acute cerebral major vessel occlusion with unknown onset (2009.4.1-2012.3.1) but without evidence of cerebral infarction on CT or MRI
Interventions/Control_2 controls: the results from MELT-Japan study
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 acute cerebral major vessel occlusion with unknown onset (2009.4.1-2012.3.1) but without evidence of cerebral infarction on CT or MRI
Key exclusion criteria Patient who did not obtain agreement for this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Iwama
Organization Graduate School of Medicine, Gifu University
Division name Neurosurgery
Zip code
Address 1-1 Yanagido, Gifu-city, Gifu, JAPAN
TEL 058-230-6271
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Yoshimura
Organization Graduate School of Medicine, GIfu University
Division name Department of Neurosurgery
Zip code
Address 1-1, Yanagido, GIfu-city, Gifu, JAPAN
TEL 058-230-6271
Homepage URL http://www.med.gifu-u.ac.jp/neurosurgery
Email s-yoshi@gifu-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Graduate School of Medicine, Gifu University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 06 Month 04 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 Completed
Date of protocol fixation
2009 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 09 Month 01 Day
Date trial data considered complete
2012 Year 09 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 03 Day
Last modified on
2013 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002490

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.