Ischemic Stroke, AcuteNCT04973332
Safety and Efficacy of SINOMED SR for Endovascular Treatment of Acute Ischemic Stroke
A study testing Intracranial thrombectomy stent in people with Ischemic Stroke, Acute and Brain Diseases, run by Sinomed Neurovita Technology Inc. at 14 sites in China.
Trial summary
A prospective, multicenter, randomized controlled, non-inferiority study to investigate the effectiveness and safety of SINOMED SR for endovascular treatment of acute ischemic stroke Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute, Brain Diseases, Cerebrovascular Disorders
- What is being tested?
- Intracranial thrombectomy stent
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 14 sitesChina
- Study dates
- 8 Aug 2021to 24 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
General inclusion criteria:
- 18 years old or more;
- NIHSS≥6 during randomization;
- Pre-onset MRS < 2;
- Acute ischemic stroke was diagnosed;
- Within 24 hours from the onset of stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed;The time point of stroke onset was defined as the time point at which the patient's last normal condition was known;
- The subject (or his/her guardian) agrees to participate in this study and signs the informed consent.
Image inclusion criteria:
- When it is less than 6h (inclusive) from the onset of stroke to the completion of femoral artery puncture, patients should be examined by cranial CT or MR;
- When it is more than 6h but less than 24h (inclusive) from the onset of stroke to the completion of femoral artery puncture, brain CT or MR should be performed and Aspects ≥6 points should be satisfied.(If immediate CT perfusion imaging or MR perfusion imaging is feasible, CTP or MRP is recommended to assist in the assessment of the infarct core, and Aspects ≥6 points shall also be satisfied);
- DSA angiography showed acute intracranial arterial occlusion, including intracranial segment of internal carotid artery (C4-C7), middle cerebral artery (M1/M2), basilar artery and intracranial segment of vertebral artery (V4).
General exclusion criteria:
- Neither MRI nor CT can be performed;
- Hemorrhagic stroke or major ischemic stroke within 6 months before enrollment;
- Severe persistent hypertension that cannot be controlled by venous hypotension, i.e., patients with SBP persistent >185mmHg and/or DBP persistent >110mmHg;
- Suppose septic emboli or suspected bacterial endocarditis;
- Renal failure, defined as: creatinine >3.0mg/dL(264 mol/L);
- Blood glucose < 2.78mmol/L (50mg/dL) or >22.20mmol/L (400mg/dL);
- decreased platelet count (< 40×109/L);
- Known bleeding tendency, defect of coagulation factor, taking anticoagulants and INR > 3.0;
- Pregnant or lactating women;
- known to be severely allergic to contrast agents and known to be allergic to nickel materials;
- The presence of diseases that may affect the assessment of neurological function (such as neurological diseases, mental diseases, etc.);
- with heart, lung, liver function failure or other serious diseases to interventional surgery;
- Participating in clinical trials of other drugs or devices;
- Life expectancy less than 6 months;
- Other conditions judged by the researcher to be unsuitable for inclusion.
Image exclusion criteria:
- CT or MR imaging evidence of intracranial hemorrhage or known bleeding tendency;
- CT/MR/DSA showed > occlusion (such as bilateral internal carotid artery occlusion at the same time, or anterior circulation and posterior circulation intracranial vessels occlusion at the same time, or internal carotid intracranial and extracranial segments occlusion at the same time);
- Carotid artery dissection, carotid initial occlusion or arteritis;
- The vascular circuitry was severe, and the intracranial thrombectomy stent was difficult to reach the target position.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Ganzhou Municipal Hospital
Ganzhou
Ganzhou People's Hospital
Ganzhou
Handan Central Hospital
Handan
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hehui
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
Jiangmen
Jinan Central Hospital
Jinan
Meizhou People's Hospital
Meizhou
The First Affiliated Hospital of Nanchang University
Nanchang
General Hospital of Eastern Theater Command, PLA
Nanjing, 210000
Qingdao Center Hospital
Qingdao
General Hospital of Northern Theater Command, PLA
Shenyang
Taiyuan Central Hospital
Taiyuan
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)
Wuhu
Central Hospital of Xiang Tan city
Xiangtan
About this study
Official title: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Study to Investigate the Effectiveness and Safety of Intracranial Embolization Stents for Endovascular Treatment of Acute Ischemic Stroke
A prospective, multicenter, randomized controlled, non-inferiority study to investigate the effectiveness and safety of SINOMED SR for endovascular treatment of acute ischemic stroke
Read the detailed description
This is a multicenter, prospective, randomized, 1:1, controlled trial with blinded outcome assessment assessing non-inferiority of SINOMED SR compared to Solitaire FR. The trial aims to randomize 220 patients 1:1 to receive SINOMED SR or Solitaire FR.The primary outcome is the Success rate of immediate recanalization.
- Being tested
- Intracranial thrombectomy stent
- Medical subject headings
- Ischemic Stroke, Brain Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial thrombectomy stentDevice
Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
| Study group | Role | What they receive |
|---|---|---|
| Thrombectomy-SINOMED SR | Experimental | Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Receives: Device: Intracranial thrombectomy stent |
| Thrombectomy-Solitaire FR | Active comparator | Intracranial thrombectomy was performed with a control product(name:Solitaire FR) Receives: Device: Intracranial thrombectomy stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Immediate Recanalization
The criteria for successful immediate recanalization were target recanalization with a mTICI grade of 2b or 3 grade
Measured: Within 24 hours post-procedure
Secondary outcomes (9)
Number of Participants With a Modified Rankin Scale (mRS) Score of 0-2 Points at 90 Days After Surgery
The Modified Rankin Scale is a global measure of functional disability ranging from 0 (no symptoms) to 6 (death), where lower scores indicate a better outcome. A score of 0-2 is commonly interpreted as a favorable functional outcome.
Measured: pre-procedure, and 90 days post-procedure
Vascular Recanalization Time
The time from femoral artery puncture to vascular recanalization or the end time of surgery for patients with no vascular recanalization. Vascular recanalization time = successful recanalization time - femoral artery puncture time
Measured: intra-operative
The National Institute of Health Stroke Scale Score Decreased the Rate of Subjects With > 4 Points
The number of subjects exhibiting a >4-point decrease on the National Institutes of Health Stroke Scale (NIHSS; range 0-42, where higher scores indicate worse neurological deficit).
Measured: 7 days post-procedure
Number of Devices Successfully Operated
Devices Successfully Operated defined devices completed conveying, releasing and retracting.
Measured: intra-operative
Number of Participants Who Experienced Symptomatic Intracranial Hemorrhage Within 24 h Post-procedure
Symptomatic intracranial hemorrhage within 24 h, specifically intracranial hemorrhage (intracranial parenchymal hematoma, subarachnoid hemorrhage, and ventricular hemorrhage) accompanied by neurological deterioration
Measured: within 24 hours post-procedure
Number of Participants Who Died Within 90 Days
The count of all deaths from any cause occurring within 90 days post-procedure among participants who received the intracranial thrombectomy stent.
Measured: within 90 days
Number of Device Defects
The count of defects (e.g., device breakage, incorrect labeling) identified in the research devices during the clinical trial.
Measured: intra-operative
Number of Participants With Serious Adverse Events (SAE)
The count of participants who experienced at least one serious adverse event (SAE) after receiving thrombectomy with the intracranial thrombectomy device.
Measured: Within 90 days post-procedure
Number of Participants With Adverse Events (AE)
The count of participants who experienced at least one adverse event (AE) after receiving thrombectomy with the intracranial thrombectomy device.
Measured: Within 90 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start8 Aug 2021
- Primary completion7 Apr 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, AcuteStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized controlled, non-infertility study
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinomed Neurovita Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The General Hospital of Eastern Theater Command
- Responsible party
- Sponsor
- Investigators
- Xinfeng Liu, Principal investigator, General Hospital of Eastern Theater Command, PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973332
- Sponsor's protocol ID
- SINOMED SR
- Status last verified
- Feb 2026
- First submitted
- 21 Jun 2021
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huo S, Gao J, Lv Q, Xie M, Wang H, Zhang X, Xie Y, Wu M, Liu R, Liu X, Yuan K, Ye R. Trajectories of stroke severity and functional outcomes after endovascular treatment in ischemic stroke: A post hoc analysis of a randomized controlled trial. Clin Neurol Neurosurg. 2024 Apr;239:108248. doi: 10.1016/j.clineuro.2024.108248. Epub 2024 Mar 16.
PubMed 38507987
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled, Non-inferiority Study to Investigate the Effectiveness and Safety of Intracranial Embolization Stents for Endovascular Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04973332
- Acronym / sponsor ID
- SINOMED SR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Sinomed Neurovita Technology Inc.Industry (pharma, biotech, devices)
- Collaborators
- The General Hospital of Eastern Theater Command
- Study start
- 8 Aug 2021 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter, randomized controlled, non-inferiority study to investigate the effectiveness and safety of SINOMED SR for endovascular treatment of acute ischemic stroke
Detailed description
This is a multicenter, prospective, randomized, 1:1, controlled trial with blinded outcome assessment assessing non-inferiority of SINOMED SR compared to Solitaire FR. The trial aims to randomize 220 patients 1:1 to receive SINOMED SR or Solitaire FR.The primary outcome is the Success rate of immediate recanalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized controlled, non-infertility study
| Arm | Type | Receives |
|---|---|---|
| Thrombectomy-SINOMED SR | Experimental | Device: Intracranial thrombectomy stentPatients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. |
| Thrombectomy-Solitaire FR | Active comparator | Device: Intracranial thrombectomy stentIntracranial thrombectomy was performed with a control product(name:Solitaire FR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Intracranial thrombectomy stentIntracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset | Device | Thrombectomy-SINOMED SR, Thrombectomy-Solitaire FR |
Primary outcome
Number of Participants With Successful Immediate Recanalization
Time frame: Within 24 hours post-procedure
The criteria for successful immediate recanalization were target recanalization with a mTICI grade of 2b or 3 grade
9 secondary outcomes
Number of Participants With a Modified Rankin Scale (mRS) Score of 0-2 Points at 90 Days After Surgery
Time frame: pre-procedure, and 90 days post-procedure
Vascular Recanalization Time
Time frame: intra-operative
The National Institute of Health Stroke Scale Score Decreased the Rate of Subjects With > 4 Points
Time frame: 7 days post-procedure
Number of Devices Successfully Operated
Time frame: intra-operative
Number of Participants Who Experienced Symptomatic Intracranial Hemorrhage Within 24 h Post-procedure
Time frame: within 24 hours post-procedure
Number of Participants Who Died Within 90 Days
Time frame: within 90 days
Number of Device Defects
Time frame: intra-operative
Number of Participants With Serious Adverse Events (SAE)
Time frame: Within 90 days post-procedure
Number of Participants With Adverse Events (AE)
Time frame: Within 90 days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38507987Huo S, Gao J, Lv Q, Xie M, Wang H, Zhang X, Xie Y, Wu M, Liu R, Liu X, Yuan K, Ye R. Trajectories of stroke severity and functional outcomes after endovascular treatment in ischemic stroke: A post hoc analysis of a randomized controlled trial. Clin Neurol Neurosurg. 2024 Apr;239:108248. doi: 10.1016/j.clineuro.2024.108248. Epub 2024 Mar 16.
- Individual participant dataSharing planned: No
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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.
Xinfeng Liu principal investigator
General Hospital of Eastern Theater Command, PLA
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracranial thrombectomy stent in people with Ischemic Stroke, Acute and Brain Diseases, run by Sinomed Neurovita Technology Inc. at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Immediate Recanalization (time frame: Within 24 hours post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04973332, which also lists 1 linked publication.
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 27 Feb 2026.