UMIN-CTR Clinical Trial

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	1
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	2021 Year 05 Month 20 Day

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