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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024199
Receipt No. R000027860
Scientific Title Safety and efficacy of laser-induced thrombolysis in thromboembolism of major cerebral arteries
Date of disclosure of the study information 2016/11/01
Last modified on 2019/04/01

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Basic information
Public title Safety and efficacy of laser-induced thrombolysis in thromboembolism of major cerebral arteries
Acronym Safety and efficacy of laser-induced thrombolysis
Scientific Title Safety and efficacy of laser-induced thrombolysis in thromboembolism of major cerebral arteries
Scientific Title:Acronym Safety and efficacy of laser-induced thrombolysis
Region
Japan

Condition
Condition Thromboembolism of major cerebral arteries
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of safety and efficacy of laser-induced thrombolysis in thromboembolism of major cerebral arteries
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Serious adverse effects related with device.
Thromboembolism in a previously uninvolved territory.
Vascular perforation and intramural arterial dissection
Hemorrhage within 24 h after operation
Death within 4 weeks after operation

Efficacy
(TICI) grades 2b and 3 flow
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Laser-induced thrombolysis
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 1. Patients had occlusions of major cerebral arteries, which were treatable by laser induced thrombolysis within 8 h of stroke symptom onset and with ineligibility for or failure to respond to intravenous rt-PA.
2. The occlusions of major cerebral arteries (intracranial internal carotid artery, frontal cerebral artery, middle cerebral artery (M1, M2), basilar artery, vertebral artery) confirmed angiographically as (TIMI) grades 0, 1.
3. mRS score 0-2 before onset.
4. Symptom of acute stroke
5.NIHSS score 4-24
6.TICI 0,1
7. Voluntary written consent by themselves or legally acceptable representative is given.
Key exclusion criteria 1. Treatment by intravenous t-PA administration within 12 weeks of IC
2. Sudden improvement of symptom of stroke
3. NIHSS score > 24 or coma
4. Women with pregnancy (possible), or lactating
5. Impossible access for vessels
6. Bleeding, in the tendency to bleeding, and family history and past history of bleeding disorders
7. Treatment of oral coagulant and PT-INR > 3.0
8.
9. APTT twice more than upper limit of normal.
10. Platelet count < 3,000 /uL
11. Uncontrolled neurological and psychological disorders
12. Hypersensitivity of contrast agent
13. Uncontrolled hypertension (maximum pressure >185 mmHg or minimum pressure > 110 mmHg)
14. One of below conditions in CT scan
Midline sift
Low density area more than one third
Intracranial hemorrhage
AVM
Aneurysm
Complete occlusion of carotid artery
15. Stenosis of arteries to be impossible for laser induced thrombolysis
16. Previous injury of artery
17. Within 90 day of alive
18. Treatment with any investigational compound within 12 weeks before IC
19. Blood sugar =< 50 mg/dL or > 400 mg/dL
20. Seizure
21. Failure of reopening by previous thrombectomy
22. Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.
23. Cerebral hemorrhage after t-PA treatment in CT scan
24.Leakage of the contrast agent before laser treatment
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Teiji
Middle name
Last name Nakayama
Organization Hamamatsu Medical Center Hospital
Division name Emergent Medical Center
Zip code 432-8580
Address 328 Tomizuka Nakaku Hamamatsu, Japan
TEL 053-453-7111
Email nakayama@hmedc.or.jp

Public contact
Name of contact person
1st name Teiji
Middle name
Last name Nakayama
Organization Hamamatsu Medical Center Hospital
Division name Emergent Medical Center
Zip code 432-8580
Address 328 Tomizuka Nakaku Hamamatsu, Japan
TEL 053-453-7111
Homepage URL
Email nakayama@hmedc.or.jp

Sponsor
Institute Hamamatsu univeristy hospital
Institute
Department

Funding Source
Organization Japan agency for medical research and development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB in Hamamatsu Medical Center Hospital
Address 328 Tomizuka Nakaku Hamamatsu, Japan
Tel 053-453-7111
Email chiken@hmedc.or.jp

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
2016 Year 11 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 3
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
2016 Year 11 Month 01 Day
Date of IRB
2016 Year 02 Month 22 Day
Anticipated trial start date
2017 Year 03 Month 30 Day
Last follow-up date
2018 Year 08 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 28 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027860

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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