NCT04973332CompletedNot Applicable
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
Sinomed Neurovita Technology Inc.14 sites in 1 country218 target enrollmentStarted: August 8, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 218
- Locations
- 14
- Primary Endpoint
- Number of Participants With Successful Immediate Recanalization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •General inclusion criteria：
- •18 years old or more;
- •NIHSS≥6 during randomization;
- •Pre-onset MRS < 2;
- •Acute ischemic stroke was diagnosed;
- •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;
- •The subject (or his/her guardian) agrees to participate in this study and signs the informed consent.
- •Image inclusion criteria：
- •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;
- •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);
- •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).
Exclusion Criteria
- •Neither MRI nor CT can be performed;
- •Hemorrhagic stroke or major ischemic stroke within 6 months before enrollment;
- •Severe persistent hypertension that cannot be controlled by venous hypotension, i.e., patients with SBP persistent >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 < 2.78mmol/L (50mg/dL) or >22.20mmol/L (400mg/dL);
- •decreased platelet count (< 40×109/L);
- •Known bleeding tendency, defect of coagulation factor, taking anticoagulants and INR > 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.
Arms & Interventions
Thrombectomy-SINOMED SR
Experimental
Patients 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.
Intervention: Intracranial thrombectomy stent (Device)
Thrombectomy-Solitaire FR
Active Comparator
Intracranial thrombectomy was performed with a control product（name:Solitaire FR）
Intervention: Intracranial thrombectomy stent (Device)
Outcomes
Primary Outcomes
Number of Participants With Successful Immediate Recanalization
Time Frame: Within 24 hours post-procedure
The criteria for successful immediate recanalization were target recanalization with a mTICI grade of 2b or 3 grade
Secondary Outcomes
- Number of Participants Who Died Within 90 Days(within 90 days)
- 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)
- Vascular Recanalization Time(intra-operative)
- The National Institute of Health Stroke Scale Score Decreased the Rate of Subjects With > 4 Points(7 days post-procedure)
- Number of Devices Successfully Operated(intra-operative)
- Number of Participants Who Experienced Symptomatic Intracranial Hemorrhage Within 24 h Post-procedure(within 24 hours post-procedure)
- Number of Device Defects(intra-operative)
- Number of Participants With Serious Adverse Events (SAE)(Within 90 days post-procedure)
- Number of Participants With Adverse Events (AE)(Within 90 days post-procedure)
Investigators
Study Sites (14)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal BleedingAcute Gastrointestinal BleedingNCT06188585Medtronic - MITG278
Completed
Phase 2
Prospective Study in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 InfectionSARS-CoV-2 (COVID-19) InfectionAdvanced or Metastatic Hematological or Solid TumorNCT04333914Centre Leon Berard19
Recruiting
Not Applicable
The Safety and Efficacy of the Suture-Mediated Closure SystemArterial PuncturePeripheral Arterial DiseaseNCT05841836Zhejiang Zylox Medical Device Co., Ltd.228
Not yet recruiting
Phase 4
CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AMLRelapsed/Refractory AMLNCT06763666Nanfang Hospital, Southern Medical University172
Active, not recruiting
Not Applicable
A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous LevelsCervical Disc DiseaseNCT04564885Spineart USA300