UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000027860