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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: Cerebrovascular Interventional Procedural Control System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. 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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Patients with acute ischemic stroke will receive interventional procedure by the Cerebrovascular Interventional Procedural Control System. | Device: Cerebrovascular Interventional Procedural Control System<br>* The Cerebrovascular Interventional Procedural Control System is intended for use in the remote delivery and manipulation of guidewires and rapid deliver stent catheters, and remote manipulation of guide catheters during cerebrovascular intervention procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Good Neurological Outcome | 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. | 90±7 Days post-treatment | 
| Technical Success | Using Cerebrovascular Interventional Procedural Control System successfully complete the catheters in placement, thrombectomy stent release, and thrombectomy system recovery, without manual conversion. | Immediately post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Revascularization | Achieving mTICI ≥2b in the target vessel within 3 passes of the cerebrovascular interventional procedural control system without the use of rescue therapy. | Immediately post-treatment | 
| Time from Groin Puncture to Reperfusion | Time from groin puncture to achievement of mTICI ≥2b | Immediately post-treatment | 
| Successful Recanalization Rate | Achieving mTICI ≥2b in the target vessel within 1 passes of the Cerebrovascular Interventional Procedural Control System without the use of rescue therapy. | Immediately post-treatment | 
| Radiation Exposure | Total fluoroscopy dose utilized during the procedure as recorded by the DSA Imaging System. | Immediately post-treatment | 
| Symptomatic Intracranial Hemorrhage | Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs. | 36 hours post-treatment | 
| Device-related Serious Adverse Events (SAEs) | Any serious adverse events related to the device, such as vessel perforation, vessel dissection, vessel rupture, and severe spasm. | Through 90 days | 
| All-cause Mortality at 90 days | Rate of mortality | Through 90 days |