Thromboembolism of major cerebral arteries
Conditions
Interventions
Laser-induced thrombolysis
Sponsors
Hamamatsu univeristy hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTeiji Nakayama
Hamamatsu Medical Center Hospital Emergent Medical Center
Outcome results
None listed