Status:
UNKNOWN
First-in-man Study of the Cerebrovascular Interventional Procedural Control System
Lead Sponsor:
Hangzhou Dinova Neuroscience Technology Co., Ltd
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
10-80 years
Phase:
NA
Brief Summary
The objective of this study the first human use of a new device in treatment of acute ischemic stroke, which to evaluate the feasibility, safety, and efficacy of the Cerebrovascular Interventional Pro...
Eligibility Criteria
Inclusion
- Age 18-80.
- Diagnosed with acute ischemic stroke.
- Arterial occlusion in the anterior cerebral circulation that was confirmed by CTA or MRA.
- Subject could be treated intraarterially within 8 hours after symptom onset.
- Prestroke Modified Rankin Score ≤ 1.
- National Institutes of Health Stroke Scale (NIHSS) ≥6 and ≤20.
- Patients or their legally authorised representatives provided signed, informed consent.
Exclusion
- NCCT ASPECT score \<6，or the infarct volume exceeded 1/3 of the middle cerebral artery blood supply area.
- CT/MR Showed midline shift or cerebral hernia, and ventricle occupying effect. Intracranial hemorrhage. CTA/MRA shows carotid artery dissection, severe stenosis, or complete occlusion, which requiring carotid stent implantation during thrombectomy; Bilateral acute stroke or multiple intracranial large vessel occlusion.
- Females who are pregnant or lactating.
- Severe allergy to contrast agents, nickel-titanium metal or its alloys.
- Drug-resistant hypertension (defined as sustained systolic blood pressure \>185mmHg or diastolic blood pressure \>110mmHg).
- Hemorrhagic tendency (including but not limited to platelet \<100\*109/L, heparin treatment within 48 hours with APTT ≥35s, taking warfarin with an INR \> 1.7).
- Surgery or biopsy of parenchymal organs within the last 1 month
- Any active or recent bleeding (gastrointestinal, urinary, etc.) within the last 1 month
- Undergoing hemodialysis or peritoneal dialysis; exist of severe renal insufficiency (serum creatinine \>220umol/L or 2.5mg/dl)
- Previous intracranial hemorrhage, subarachnoid hemorrhage, brain tumor.
- Life expectancy of less than 1 year.
- Enrollment in another clinical trial evaluating other devices or drugs during the same period.
- Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.
Key Trial Info
Start Date :
October 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05972252
Start Date
October 15 2023
End Date
March 31 2024
Last Update
October 18 2023
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China