First-in-man Study of the Cerebrovascular Interventional Procedural Control System

Hangzhou Dinova Neuroscience Technology

Status: Enrolling

Conditions: Acute Ischemic Stroke

Treatments: Device: Cerebrovascular Interventional Procedural Control System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05972252

DNS-CIPCS-01

Details and patient eligibility

About

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 Procedural Control System.

Enrollment: 10 estimated patients

Sex: All

Ages: 10 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-80.
2. Diagnosed with acute ischemic stroke.
3. Arterial occlusion in the anterior cerebral circulation that was confirmed by CTA or MRA.
4. Subject could be treated intraarterially within 8 hours after symptom onset.
5. Prestroke Modified Rankin Score ≤ 1.
6. National Institutes of Health Stroke Scale (NIHSS) ≥6 and ≤20.
7. Patients or their legally authorised representatives provided signed, informed consent.

Exclusion criteria

1. NCCT ASPECT score <6，or the infarct volume exceeded 1/3 of the middle cerebral artery blood supply area.
2. 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.
3. Females who are pregnant or lactating.
4. Severe allergy to contrast agents, nickel-titanium metal or its alloys.
5. Drug-resistant hypertension (defined as sustained systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg).
6. 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).
7. Surgery or biopsy of parenchymal organs within the last 1 month
8. Any active or recent bleeding (gastrointestinal, urinary, etc.) within the last 1 month
9. Undergoing hemodialysis or peritoneal dialysis; exist of severe renal insufficiency (serum creatinine >220umol/L or 2.5mg/dl)
10. Previous intracranial hemorrhage, subarachnoid hemorrhage, brain tumor.
11. Life expectancy of less than 1 year.
12. Enrollment in another clinical trial evaluating other devices or drugs during the same period.
13. Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Experimental Group

Experimental group

Description:

Patients with acute ischemic stroke will receive interventional procedure by the Cerebrovascular Interventional Procedural Control System.

Treatment:

Device: Cerebrovascular Interventional Procedural Control System