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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972252
• Other study ID #: DNS-CIPCS-01
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: October 2023
• Source: Hangzhou Dinova Neuroscience Technology Co., Ltd
• Contact: Vico Wang
• Phone: +8657156105021
• Email: neuroscience[@]dnamedtech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke

Intervention

Device:
• Cerebrovascular Interventional Procedural Control System
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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Dinova Neuroscience Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Time from Groin Puncture to Reperfusion	Time from groin puncture to achievement of mTICI =2b	Immediately post-treatment
Secondary	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
Secondary	Radiation Exposure	Total fluoroscopy dose utilized during the procedure as recorded by the DSA Imaging System.	Immediately post-treatment
Secondary	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
Secondary	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
Secondary	All-cause Mortality at 90 days	Rate of mortality	Through 90 days