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

Hangzhou Dinova Neuroscience Technology Co., Ltd1 site in 1 country10 target enrollmentOctober 15, 2023

ConditionsAcute Ischemic Stroke

Overview

Phase: N/A
Intervention: Not specified
Conditions: Acute Ischemic Stroke
Sponsor: Hangzhou Dinova Neuroscience Technology Co., Ltd
Enrollment: 10
Locations: 1
Primary Endpoint: Good Neurological Outcome
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 Procedural Control System.

Registry

clinicaltrials.gov

Start Date

October 15, 2023

End Date

March 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hangzhou Dinova Neuroscience Technology Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 ≤
•National Institutes of Health Stroke Scale (NIHSS) ≥6 and ≤
•Patients or their legally authorised representatives provided signed, informed consent.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Good Neurological Outcome

Time Frame: 90±7 Days post-treatment

Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days. mRS 0-2 indicates functional independence 0 - No symptoms.

Technical Success

Time Frame: Immediately post-treatment

Using Cerebrovascular Interventional Procedural Control System successfully complete the catheters in placement, thrombectomy stent release, and thrombectomy system recovery, without manual conversion.