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New stent shows promise for clot removal in stroke patients

NCT ID NCT04973332

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

218 people

The number who actually took part.

Started

Aug 2021

Finished

Jun 2022

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Central Hospital of Xiang Tan city

    Xiangtan, China

  • Ganzhou Municipal Hospital

    Ganzhou, China

  • Ganzhou People's Hospital

    Ganzhou, China

  • General Hospital of Eastern Theater Command, PLA

    Nanjing, 210000, China

  • General Hospital of Northern Theater Command, PLA

    Shenyang, China

  • Handan Central Hospital

    Handan, China

  • Jiangmen Wuyi Hospital of Traditional Chinese Medicine

    Jiangmen, China

  • Jinan Central Hospital

    Jinan, China

  • Meizhou People's Hospital

    Meizhou, China

  • Qingdao Center Hospital

    Qingdao, China

  • Taiyuan Central Hospital

    Taiyuan, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, China

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hehui, China

  • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)

    Wuhu, China

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