First human use of a new device for treating acute ischemic stroke

A Feasibility Study to Evaluate the Safety and Efficacy of the Cerebrovascular Interventional Procedural Control System in Treatment of Acute Ischemic Stroke

This study is testing a new device to see if it can help people with acute ischemic stroke by restoring blood flow within 8 hours of their symptoms starting.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 10 Years to 80 Years
• Sex: All
• Sponsor: Hangzhou Dinova Neuroscience Technology Co., Ltd (industry)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05972252 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility, safety, and efficacy of the Cerebrovascular Interventional Procedural Control System in patients with acute ischemic stroke. It involves the first human application of this innovative device, focusing on patients who can be treated intra-arterially within 8 hours of symptom onset. The study aims to determine how well this device can restore blood flow in cases of arterial occlusion in the anterior cerebral circulation. Participants will be closely monitored for outcomes related to their stroke condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 diagnosed with acute ischemic stroke and able to receive treatment within 8 hours of symptom onset.

Not a fit: Patients with severe stroke complications, such as significant infarct volume or midline shift, may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could significantly improve treatment outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: While this approach is novel, similar studies involving innovative devices for stroke treatment have shown promise in the past.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing

• Beijing Tiantan Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Vico Wang

Conditions: Acute Ischemic Stroke