First-in-man Study of the Cerebrovascular Interventional Procedural Control System
NCT ID: NCT05972252
Last Updated: 2023-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
10 participants
INTERVENTIONAL
2023-10-15
2024-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Testing of a System for Remote Ischemic Conditioning in Cerebral Small Vessel Disease and Pre-hospital Stroke Care
NCT05967728
Endovascular treatmenT for Acute Ischemic Stroke in China (DETECT2-China)
NCT05092139
Remote Ischemic Conditioning for Chronic Cerebral Artery Occlusion
NCT05342714
Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke
NCT05719688
a Cohort Study of Ischemic Cerebrovascular Disease
NCT05922540
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Group
Patients with acute ischemic stroke will receive interventional procedure by the Cerebrovascular Interventional Procedural Control System.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
10 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hangzhou Dinova Neuroscience Technology Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Feng Gao, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DNS-CIPCS-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.