N/A
N=218
Safety and Efficacy of SINOMED SR for Endovascular Treatment of Acute Ischemic Stroke
Ischemic Stroke, Acute · Brain Diseases · Cerebrovascular Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04973332 ↗Enrolled (actual)
218
Serious AEs
36.2%
Results posted
Feb 2026
Primary outcome: Primary: Number of Participants With Successful Immediate Recanalization — 105; 103 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intracranial thrombectomy stent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sinomed Neurovita Technology Inc.
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Immediate Recanalization |
105; 103 | — |
| SECONDARY Number of Participants With a Modified Rankin Scale (mRS) Score of 0-2 Points at 90 Days After Surgery |
48; 43 | — |
| SECONDARY Vascular Recanalization Time |
95.55; 79.58 | — |
| SECONDARY The National Institute of Health Stroke Scale Score Decreased the Rate of Subjects With > 4 Points |
66; 50 | — |
| SECONDARY Number of Devices Successfully Operated |
112; 112 | — |
| SECONDARY Number of Participants Who Experienced Symptomatic Intracranial Hemorrhage Within 24 h Post-procedure |
2; 1 | — |
| SECONDARY Number of Participants Who Died Within 90 Days |
23; 33 | — |
| SECONDARY Number of Device Defects |
0; 0 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAE) |
33; 46 | — |
| SECONDARY Number of Participants With Adverse Events (AE) |
104; 103 | — |
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
Eligibility Criteria
General inclusion criteria：
- 18 years old or more;
- NIHSS≥6 during randomization;
- Pre-onset MRS 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 22.20mmol/L (400mg/dL);
- decreased platelet count ( 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.
Data sourced from ClinicalTrials.gov (NCT04973332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.