To evaluate the safety and efficacy of Solitaire thrombectomy in Chinese patients with acute stroke within 12 hours of symptom onset.
This study is a multicenter, prospective, control study. Patients with acute ischemic stroke who meet inclusion criteria would be enrolled in the study. If the patient or patient's legally authorized representative decides that the patient should receive the intervention operation and signs the informed consent of intervention operation, the patient will be assigned to the intervention group. If the patient participates in the EAST study but refuses intervention after notified of all the benefits and risk of intervention and conservative treatment, the patient will be assigned to the control group.There will be 150 patients enrolled in each group. Patients in the intervention group will be treated with mechanical recanalization using Solitaire plus standard medical therapy. Patients in the control group will receive standard medical therapy alone.
All patients were followed up for 90 days upon enrollment. During the trial, multiple indicators will be assessed in all patients at baseline, 24hours,14days (or at discharge, whichever occurs first) and 90 days. Primary efficacy endpoint will be functional independence as defined by modified Rankin Scale (mRS) score ≤ 2 at 90 days or function improvement by mRS shift analysis.Primary procedure efficacy endpoint will be arterial recanalization of the occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI) score equal or superior to 2b right following the use of the Study Device. Primary safety endpoint is systematic ICH with 24 ±3hrs post procedure.The secondary endpoints include: rate of device-related and procedure related Serious Adverse Events (SAEs) at 14 days or discharge; volume of cerebral infarction as measured by a CT scan at 24 ±3hrs post procedure; arterial reperfusion measured by reperfusion ratio on CT scan 24 ±3hrs post procedure; infarction in subjects who achieved TICI 2b‐3 reperfusion without intracranial hemorrhage;death due to any cause at 14days or discharge and at 90 days; change in NIHSSat 24±3hrs post procedure;change in NIHSS at 14 days or discharge post procedure; change in NIHSSat 90 ± 7days; quality of life at 90± 7days; the proportion of patients who suffer a Safety Outcome : the proportion of patients with the composite of: (i) symptomatic intracranial hemorrhage (ii) major bleeding due to femoral artery access complications including groin hematoma, retroperitoneal hematoma (iii) contrast nephropathy;economic (cost-effectiveness) analysis;evaluation of waiver/deferral of consent process; the total radiation dose (CT, CTA, angiography) reported as a continuous measure;the proportion of patients with malignant MCA infarction;the proportion of patients undergoing hemicraniectomy.
Because a substantial number of patients are expected to have intracranial atherosclerosis, subgroup analysis will also be carried out on this group of patient. The clinical outcomes, the final TICI score after angioplasty and possible stenting, and symptomatic ICH (including SAH) and immediate re-thrombosis rate will be included in the subgroup analysis.
- Interventional treatment with Solitaire Device
Intervention Desc: Patients will be treated for mechanical recanalization with Solitaire within 12 hours after stroke onset plus standard medical management. ARM 1: Kind: Experimental Label: Solitaire Device
- Standard Medical Management Other
Intervention Desc: Standard Medical Management:Treated with standard medical management. ARM 1: Kind: Experimental Label: Medical treatment ARM 2: Kind: Experimental Label: Solitaire Device Description: Interventional treatment with Solitaire. After the procedure, the patients will be admitted to intensive care unit. Standard medical management will be provided to these patients.
- Allocation: Non-Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Functional independence as defined by modified Rankin Scale (mRS) score ≤ 2 at 90 days or by functional improvement as defined by mRS using shift analysis||90 days||No|
|Primary||Arterial recanalization of the occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI) score equal or superior to 2b right following the use of the Study Device||24hours||No|
|Primary||Systematic ICH with 24 ±3hrs post procedure||24 hours||Yes|
|Secondary||Rate of device-related and procedure related Serious Adverse Events (SAEs) at 7 days or discharge||7days||Yes|
|Secondary||Volume of cerebral infarction as measured by a CT scan at 24 ±3hrs post procedure||24 hours||No|
|Secondary||Arterial reperfusion measured by reperfusion ratio on CT scan 24 ±3hrs post procedure||24 hours||No|
|Secondary||Infarction in subjects who achieved TICI 2b‐3 reperfusion without intracranial hemorrhage||24 hours||Yes|
|Secondary||Death due to any cause at 14days or discharge and at 90 days||90 days||Yes|
|Secondary||Change in NIHSS at 24±3hrs post procedure||24 hours||Yes|
|Secondary||Change in NIHSS at 14 days or discharge post procedure||14 days||No|
|Secondary||Change in NIHSS at 90 ± 7days||90 days||No|
|Secondary||Quality of life at at90 ± 7days(EQ-5D,BI)||90 days||No|
|Secondary||The proportion of patients who suffer a Safety Outcome||90 days||No|
|Secondary||Economic (cost-effectiveness) analysis||90 days||No|
|Secondary||Evaluation of waiver/deferral of consent process||90 days||No|
|Secondary||The total radiation dose (CT, CTA, angiography) reported as a continuous measure||90 days||No|
|Secondary||The proportion of patients with malignant MCA infarction||90 days||No|
|Secondary||The proportion of patients undergoing hemicraniectomy||90 days||No|
|Secondary||Subgroup analysis of reperfusion in patients with intracranial atherosclerosis||90 days||No|