Brain Diseases, Cerebrovascular Disorders, Ischemic Stroke, Acute
Conditions
Brief 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
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.
Interventions
DEVICEIntracranial thrombectomy stent
Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
Sponsors
Sinomed Neurovita Technology Inc.
The General Hospital of Eastern Theater Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicenter, randomized controlled, non-infertility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Immediate Recanalization | Within 24 hours post-procedure | The criteria for successful immediate recanalization were target recanalization with a mTICI grade of 2b or 3 grade |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Device Defects | intra-operative | The count of defects (e.g., device breakage, incorrect labeling) identified in the research devices during the clinical trial. |
| Number of Participants With a Modified Rankin Scale (mRS) Score of 0-2 Points at 90 Days After Surgery | pre-procedure, and 90 days post-procedure | 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. |
| Vascular Recanalization Time | intra-operative | 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 |
| The National Institute of Health Stroke Scale Score Decreased the Rate of Subjects With > 4 Points | 7 days post-procedure | 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). |
| Number of Devices Successfully Operated | intra-operative | Devices Successfully Operated defined devices completed conveying, releasing and retracting. |
| Number of Participants Who Experienced Symptomatic Intracranial Hemorrhage Within 24 h Post-procedure | within 24 hours post-procedure | Symptomatic intracranial hemorrhage within 24 h, specifically intracranial hemorrhage (intracranial parenchymal hematoma, subarachnoid hemorrhage, and ventricular hemorrhage) accompanied by neurological deterioration |
| Number of Participants With Serious Adverse Events (SAE) | Within 90 days post-procedure | The count of participants who experienced at least one serious adverse event (SAE) after receiving thrombectomy with the intracranial thrombectomy device. |
| Number of Participants Who Died Within 90 Days | 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. |
| Number of Participants With Adverse Events (AE) | Within 90 days post-procedure | The count of participants who experienced at least one adverse event (AE) after receiving thrombectomy with the intracranial thrombectomy device. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXinfeng Liu
General Hospital of Eastern Theater Command, PLA
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.36 years STANDARD_DEVIATION 9.98 |
| Pre-onset mRS < 2 | 109 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment China | 109 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 23 / 109 | 33 / 109 |
| other Total, other adverse events | 103 / 109 | 94 / 109 |
| serious Total, serious adverse events | 33 / 109 | 46 / 109 |
Outcome results
None listed