About this trial
We will conduct a multicenter, prospective, randomized, open-label, blinded endpoint trial with a non-inferiority design in patients who present 6 to 24 hours after symptom onset with LVO. Patients who meet eligibility criteria will be randomly assigned to the Non-perfusion or Perfusion group with a 1:1 ratio. In the Non-perfusion group, patients with penumbra-core mismatch (defined as the FLAIR Vascular Hyperintensity (FVH) extending beyond the boundary of the DWI cortical lesions) will receive EVT. In the Perfusion group, patients with perfusion mismatch (defined as regional cerebral blood flow (\<30%) \< 70 ml with mismatch ratio ≥ 1.8 and mismatch volume ≥ 15 ml) will receive EVT. Patients in both groups will receive guideline-based medical treatment. If patients in both groups do not meet the criteria for EVT, only guideline-based medical treatment will be administered.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age of 18 years or older;
Anterior circulation LVO (internal carotid artery, or middle cerebral arteries (MCA)M1, M2 proximal segment) confirmed by computed tomographic angiography (CTA)/magnetic resonance angiography (MRA);
NIHSS score ≥6 at the time of randomization;
ASPECTS score ≥ 6 on NCCT;
Disqualifiers
Pregnancy, or those potential with positive urine or serum beta Human Chorionic Gonadotrop in test;
A history of severe allergy to contrast media;
Uncontrolled hypertension (SBP >185mmHg; DBP>110mmHg);
Hereditary or acquired bleeding tendency, coagulation factor deficiency, recent anticoagulant medication (A platelet count of less than 100 x 109 /L;INR>3 or PPT more than 3 times normal);
Trial design
Parallel
Treatments tested in this trial
Endovascular
Procedure/SurgeryEndovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices.Remedial measures after failed thrombectomy are permitted by pharmacologic arterial thrombolysis or intravenous infusion of antiplatelet drugs, such as tirofiban or rt-PA
Drug
Drugbest drug conservative therapy could be uesd in patients who with no indication of surgery
Treatment groups
Trial outcomes
Primary outcomes
Functionally independent outcome in all enrolled patients
defined as patients with a mRS Score of 0-2 at 90 days (mRS 90d(Scores on the modified Rankin scale range from 0 to 6, with 0 indicating no symptoms, 1 no clinically significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability, and 6 death,) of a randomized group of modified intention-to-treat (mITT) patients (defined as patients with acute macrovascular occlusions treated optimally with endovascular or pharmacologic therapy) at 90 days (with an assessment time window of ±14 days) and analyzed for noninferiority.
Secondary outcomes
Modified Rankin scale scores at 90 days
(mRS 90d(Scores on the modified Rankin scale range from 0 to 6, with 0 indicating no symptoms, 1 no clinically significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability, and 6 death,) of a randomized group of modified intention-to-treat (mITT) patients (defined as patients with acute macrovascular occlusions treated optimally with endovascular or pharmacologic therapy) at 90 days (with an assessment time window of ±14 days) and analyzed for noninferiority.
Successful reperfusion after endovascular treatment
extended Thrombolysis in Cerebral Infarction (eTICI) score of 2b, 2c or 3.
Recanalization rate
Number of subjects who achieved successful reperfusion/total number of subjects who received endovascular treatment, confirmed by MRA, CTA, or digital subtraction angiography (DSA).
Final infarct volume
change from baseline in the infarct volume as calculated by CBF or DWI.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.