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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Intracranial thrombectomy stent
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:

  1. 18 years old or more;
  2. NIHSS≥6 during randomization;
  3. Pre-onset MRS < 2;
  4. Acute ischemic stroke was diagnosed;
  5. 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;
  6. The subject (or his/her guardian) agrees to participate in this study and signs the informed consent.

Image inclusion criteria:

  1. 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;
  2. 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);
  3. 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:

  1. Neither MRI nor CT can be performed;
  2. Hemorrhagic stroke or major ischemic stroke within 6 months before enrollment;
  3. Severe persistent hypertension that cannot be controlled by venous hypotension, i.e., patients with SBP persistent >185mmHg and/or DBP persistent >110mmHg;
  4. Suppose septic emboli or suspected bacterial endocarditis;
  5. Renal failure, defined as: creatinine >3.0mg/dL(264 mol/L);
  6. Blood glucose < 2.78mmol/L (50mg/dL) or >22.20mmol/L (400mg/dL);
  7. decreased platelet count (< 40×109/L);
  8. Known bleeding tendency, defect of coagulation factor, taking anticoagulants and INR > 3.0;
  9. Pregnant or lactating women;
  10. known to be severely allergic to contrast agents and known to be allergic to nickel materials;
  11. The presence of diseases that may affect the assessment of neurological function (such as neurological diseases, mental diseases, etc.);
  12. with heart, lung, liver function failure or other serious diseases to interventional surgery;
  13. Participating in clinical trials of other drugs or devices;
  14. Life expectancy less than 6 months;
  15. Other conditions judged by the researcher to be unsuitable for inclusion.

Image exclusion criteria:

  1. CT or MR imaging evidence of intracranial hemorrhage or known bleeding tendency;
  2. 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);
  3. Carotid artery dissection, carotid initial occlusion or arteritis;
  4. 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

Other trials in China

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 groups in NCT04973332
Study groupRoleWhat they receive
Thrombectomy-SINOMED SRExperimentalPatients 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 FRActive comparatorIntracranial 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. Number of Devices Successfully Operated

    Devices Successfully Operated defined devices completed conveying, releasing and retracting.

    Measured: intra-operative

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  1. First posted22 Jul 2021
  2. Study start8 Aug 2021
  3. Primary completion7 Apr 2022
  4. Study completion24 Jun 2022

Resources

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)
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
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

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.

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