UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024199 |
|---|---|
| Receipt number | 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 11:35:12 |
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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
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
nakayama@hmedc.or.jp
Sponsor or person
Institute
Hamamatsu univeristy hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027860
