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

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Device: Cerebrovascular Interventional Procedural Control System

• Registration Number: NCT05972252
• Lead Sponsor: Hangzhou Dinova Neuroscience Technology Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-08-02
• Status Verified: 2023-10
• Study Start: 2023-10-15
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Good Neurological Outcome	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	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.

Secondary Outcome Measures

Name	Time	Method
All-cause Mortality at 90 days	Through 90 days	Rate of mortality
Radiation Exposure	Immediately post-treatment	Total fluoroscopy dose utilized during the procedure as recorded by the DSA Imaging System.
Symptomatic Intracranial Hemorrhage	36 hours post-treatment	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.
Successful Recanalization Rate	Immediately post-treatment	Achieving mTICI ≥2b in the target vessel within 1 passes of the Cerebrovascular Interventional Procedural Control System without the use of rescue therapy.
Successful Revascularization	Immediately post-treatment	Achieving mTICI ≥2b in the target vessel within 3 passes of the cerebrovascular interventional procedural control system without the use of rescue therapy.
Time from Groin Puncture to Reperfusion	Immediately post-treatment	Time from groin puncture to achievement of mTICI ≥2b
Device-related Serious Adverse Events (SAEs)	Through 90 days	Any serious adverse events related to the device, such as vessel perforation, vessel dissection, vessel rupture, and severe spasm.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China