New stent shows promise for clot removal in stroke patients
NCT ID NCT04973332
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed trial tested a new stent (SINOMED SR) for removing blood clots in 218 people with acute ischemic stroke. The stent was used within 24 hours of symptom onset. The main goal was to see if the stent could successfully reopen blocked brain arteries. Researchers also tracked how well patients recovered 90 days later.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intracranial thrombectomy stent (SINOMED SR)
- What this could lead to
- If successful, this stent could provide a safe and effective option for removing blood clots in stroke patients within 24 hours of symptoms, potentially improving recovery.
- What could go wrong
- This is a non-inferiority study, meaning it aims to show the new stent is as good as existing ones, not necessarily better. The trial is completed but results may not apply to all stroke types or patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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218 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Jun 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Central Hospital of Xiang Tan city
Xiangtan, China
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Ganzhou Municipal Hospital
Ganzhou, China
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Ganzhou People's Hospital
Ganzhou, China
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General Hospital of Eastern Theater Command, PLA
Nanjing, 210000, China
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General Hospital of Northern Theater Command, PLA
Shenyang, China
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Handan Central Hospital
Handan, China
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Jiangmen Wuyi Hospital of Traditional Chinese Medicine
Jiangmen, China
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Jinan Central Hospital
Jinan, China
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Meizhou People's Hospital
Meizhou, China
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Qingdao Center Hospital
Qingdao, China
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Taiyuan Central Hospital
Taiyuan, China
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The First Affiliated Hospital of Nanchang University
Nanchang, China
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The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hehui, China
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The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)
Wuhu, China
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