Acute Ischemic Stroke
Conditions
Brief summary
As this will be a pre-market registration trial, in which devices will be used in accordance with appropriately labeled indications, pre-study notifications and approval requests will be addressed with CFDA. All trial results will be shared with CFDA.
Interventions
DEVICEStent Retriever
Stent Retriever for acute ischemic stroke
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject must demonstrate clinical signs and symptoms that are attributable to the targeted lesion and are consistent with the diagnosis of acute ischemic stroke (AIS), as confirmed by a neuroradiologist (or equivalent expert), using appropriate imaging. Arterial occlusion of ICA, MCA-M1 or MCA-M2. * Female or male subject, who, at the time of consenting, is aged between 18 and 80 years, inclusive. * Within 6 hours of stroke symptom onset, subject must have undergone treatment initiation (vascular access through puncture or cut down). * Signed Informed Consent Form (ICF) completed by subject or subject's legal representative.
Exclusion criteria
* 1\. Functional dependence prior to stroke onset, defined as a pre-stroke modified Rankin Scale (mRS) score of ≥2. * 2\. Subject's baseline NIHSS score \<2 or \>25. * 3\. History of severe head injury within past 90 days with residual neurological deficit, as determined by medical history. * 4\. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor. * 5\. Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment. * 6\. Subject has a known hemorrhagic diathesis, coagulation factor deficiency; or, is on oral anticoagulant therapy and has an International Normalized Ratio (INR) \>3. * 7\. Subject's baseline platelet count is \<30\*10\^9/L. * 8\. Subject's baseline glucose is \<50 mg/dL (2.78 mmol/L) or \>400 mg/dL (22.2 mmol/L). * 9\. Renal failure, as defined by a serum creatinine \>3.0 mg/dL (264 µmol/L) \[NOTE: subjects on renal dialysis may be treated regardless of serum creatinine levels\]. * 10\. Severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mmHg) \[if the blood pressure can be successfully reduced and maintained at the acceptable level, using medication, the patient can be enrolled\]. * 11\. Subject has known allergy or contraindication to one or more of the following: anti-platelet drugs; contrast dye; and/or, local or general anesthesia. * 12\. Subject has known allergy to nickel, cobalt chromium, tungsten, platinum or other metal that may be a component of a required medical device needed for treatment. * 13\. Subject is generally unsuitable for endovascular intervention or anesthesia. * 14\. Subject has had major surgery within the previous 30 days * 15\. Subject is an active participant in another drug or device treatment trial for any disease state; or, subject is expected to start participation in another drug or device trial while enrolled in this protocol. * 16\. Subject currently has infective endocarditis or other severe, active bacterial infection. * 17\. Subject's life expectancy is less than 6 months. * 18\. Female of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission. Imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Recanalization Rate | immediate post-thrombectomy (t-0) and no later than 3 hours' post-procedure (t-3) | Defined as modified treatment in cerebral infarction (mTICI) ≥ 2b |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from puncture to mTICI≥2b | immediate post-thrombectomy (t-0) | Time from puncture to mTICI≥2b |
| The NIHSS score at 30H post-treatment | 30± 6 hours' post-treatment | The NIHSS score at 30H post-treatment |
| Symptomatic intracranial hemorrhage(sICH) within 30H post-treatment | 30±6 hours' post-treatment | Any intracranial hemorrhage judged by CT(or MRI) with neurological symptoms |
| mRS at D90 | 90± 14 days' post-treatment | The modified Rankin Scale (mRS), a combined clinical/functionality and secondary safety endpoint, reflects the degree of disability or dependence in activities of daily living among treated patients. Though listed and classified separately, in multiple publications, as a functionality or clinical endpoint and because of its prominent and unique value in stroke trials, mRS should be considered first among key safety parameters in subjects who complete the 90-day evaluation. A successful endpoint will be defined as follows: at 90± 14 days' post-treatment, the frequency of mRS scores ≤2 or a post-treatment decrease in mRS score of ≥2, relative to the baseline determination. Patients who die, between thrombectomy initiation and 90-Days, will be given an mRS value of 6 in this analysis. |
| AE/SAE within 90D post-treatment | 90± 14 days' post-treatment | Any cause AE/SAEs within 90D post-treatment |
| Stentretriever/procedure/stroke related AE/SAEs within 90D post-treatment | 90± 14 days' post-treatment | Stentretriever/procedure/stroke related AE/SAEs within 90D post-treatment |
| Death within 90D post-treatment | 90± 14 days' post-treatment | Any cause death within 90D post-treatment |
Countries
China
Outcome results
None listed