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

Primary Purpose

Acute Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cerebrovascular Interventional Procedural Control System
Sponsored by
Hangzhou Dinova Neuroscience Technology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Technical Success
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

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.
Time from Groin Puncture to Reperfusion
Time from groin puncture to achievement of mTICI ≥2b
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.
Radiation Exposure
Total fluoroscopy dose utilized during the procedure as recorded by the DSA Imaging System.
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.
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.
All-cause Mortality at 90 days
Rate of mortality

Full Information

First Posted
July 25, 2023
Last Updated
October 16, 2023
Sponsor
Hangzhou Dinova Neuroscience Technology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05972252
Brief Title
First-in-man Study of the Cerebrovascular Interventional Procedural Control System
Official Title
A Feasibility Study to Evaluate the Safety and Efficacy of the Cerebrovascular Interventional Procedural Control System in Treatment of Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Dinova Neuroscience Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Patients with acute ischemic stroke will receive interventional procedure by the Cerebrovascular Interventional Procedural Control System.
Intervention Type
Device
Intervention Name(s)
Cerebrovascular Interventional Procedural Control System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Good Neurological Outcome
Description
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.
Time Frame
90±7 Days post-treatment
Title
Technical Success
Description
Using Cerebrovascular Interventional Procedural Control System successfully complete the catheters in placement, thrombectomy stent release, and thrombectomy system recovery, without manual conversion.
Time Frame
Immediately post-treatment
Secondary Outcome Measure Information:
Title
Successful Revascularization
Description
Achieving mTICI ≥2b in the target vessel within 3 passes of the cerebrovascular interventional procedural control system without the use of rescue therapy.
Time Frame
Immediately post-treatment
Title
Time from Groin Puncture to Reperfusion
Description
Time from groin puncture to achievement of mTICI ≥2b
Time Frame
Immediately post-treatment
Title
Successful Recanalization Rate
Description
Achieving mTICI ≥2b in the target vessel within 1 passes of the Cerebrovascular Interventional Procedural Control System without the use of rescue therapy.
Time Frame
Immediately post-treatment
Title
Radiation Exposure
Description
Total fluoroscopy dose utilized during the procedure as recorded by the DSA Imaging System.
Time Frame
Immediately post-treatment
Title
Symptomatic Intracranial Hemorrhage
Description
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.
Time Frame
36 hours post-treatment
Title
Device-related Serious Adverse Events (SAEs)
Description
Any serious adverse events related to the device, such as vessel perforation, vessel dissection, vessel rupture, and severe spasm.
Time Frame
Through 90 days
Title
All-cause Mortality at 90 days
Description
Rate of mortality
Time Frame
Through 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vico Wang
Phone
+8657156105021
Email
neuroscience@dnamedtech.com
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Gao, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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