Acute Ischemic StrokeNCT05972252
First-in-man Study of the Cerebrovascular Interventional Procedural Control System
A study of Acute Ischemic Stroke, run by Hangzhou Dinova Neuroscience Technology Co., Ltd at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality
Feng Gao, MD
About this study
Official title: A Feasibility Study to Evaluate the Safety and Efficacy of the Cerebrovascular Interventional Procedural Control System in Treatment of Acute Ischemic Stroke
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Cerebrovascular Interventional Procedural Control System
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebrovascular Interventional Procedural Control SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients with acute ischemic stroke will receive interventional procedure by the Cerebrovascular Interventional Procedural Control System. Receives: Device: Cerebrovascular Interventional Procedural Control System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately post-treatment
Secondary outcomes (7)
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.
Measured: Immediately post-treatment
Time from Groin Puncture to Reperfusion
Time from groin puncture to achievement of mTICI ≥2b
Measured: 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.
Measured: Immediately post-treatment
Radiation Exposure
Total fluoroscopy dose utilized during the procedure as recorded by the DSA Imaging System.
Measured: 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.
Measured: 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.
Measured: Through 90 days
All-cause Mortality at 90 days
Rate of mortality
Measured: Through 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start15 Oct 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Dinova Neuroscience Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972252
- Sponsor's protocol ID
- DNS-CIPCS-01
- Status last verified
- Oct 2023
- First submitted
- 25 Jul 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the Safety and Efficacy of the Cerebrovascular Interventional Procedural Control System in Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05972252
- Acronym / sponsor ID
- DNS-CIPCS-01
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hangzhou Dinova Neuroscience Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Cerebrovascular Interventional Procedural Control SystemPatients with acute ischemic stroke will receive interventional procedure by the Cerebrovascular Interventional Procedural Control System. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebrovascular Interventional Procedural Control SystemThe 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. | Device | Experimental Group |
Primary outcome
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.
7 secondary outcomes
Successful Revascularization
Time frame: Immediately post-treatment
Time from Groin Puncture to Reperfusion
Time frame: Immediately post-treatment
Successful Recanalization Rate
Time frame: Immediately post-treatment
Radiation Exposure
Time frame: Immediately post-treatment
Symptomatic Intracranial Hemorrhage
Time frame: 36 hours post-treatment
Device-related Serious Adverse Events (SAEs)
Time frame: Through 90 days
All-cause Mortality at 90 days
Time frame: Through 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acute Ischemic Stroke, run by Hangzhou Dinova Neuroscience Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vico Wang (+8657156105021, neuroscience@dnamedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good Neurological Outcome (time frame: 90±7 Days post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.