UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002809 |
|---|---|
| Receipt number | R000003418 |
| Scientific Title | Clinical study regarding angioplasty and intraarterial-tPA for intravenous-tPA resistant patients with hyperacute ischemic stroke |
| Date of disclosure of the study information | 2009/11/28 |
| Last modified on | 2009/11/28 00:04:23 |
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Basic information
Public title
Clinical study regarding angioplasty and intraarterial-tPA for intravenous-tPA resistant patients with hyperacute ischemic stroke
Acronym
Transluminal angioplasty and IA-tPA for IV-tPA resistant patient
Scientific Title
Clinical study regarding angioplasty and intraarterial-tPA for intravenous-tPA resistant patients with hyperacute ischemic stroke
Scientific Title:Acronym
Transluminal angioplasty and IA-tPA for IV-tPA resistant patient
Region
| Japan |
Condition
Condition
Hyperacute cerebral major vessel occlusion
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to know the safety and efficacy of intraarterial administration of tPA and angioplasty for intravenous tPA resistant patient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADL (modified Rankin scale) at 90 days after the treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
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
intraarterial tPA administration and percutaneous transluminal angioplasty
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient received intravenous tPA within 3 hours after onset, and resistant to this treatment both neurologically and angiographically
Key exclusion criteria
When intravascular treatment is judged as difficult
Target sample size
60
Research contact person
Name of lead principal investigator
| 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
+81-58-230-6271
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
+81-58-230-6271
Homepage URL
s-yoshi@gifu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Gifu University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2009 | Year | 11 | Month | 28 | 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
| 2009 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | 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
| 2009 | Year | 11 | Month | 28 | Day |
Last modified on
| 2009 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003418
