The investigators initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of perfusion-guided endovascular treatment (EVT) compared to standard medical care for patients with acute ischemic stroke due to medium vessel occlusion (MeVO) within 24 hours from symptom onset.
Adult acute ischemic stroke patients due to primary medium vessel occlusions (non-dominant proximal M2 or mid-distal M2/M3 segments of the middle cerebral artery, A1/A2/A3 segments of the anterior cerebral artery, and P1/P2/P3 segments of the posterior cerebral artery) confirmed by CTA/MRA and responsible for the signs and symptoms of acute ischemic stroke with baseline National Institutes of Health Stroke Scale (NIHSS) ≥8 will be enrolled in this trial. The investigators use perfusion imaging to select subjects and the enrolled patients have target mismatch profile on CTP or MRI+PWI (ischemic core volume \<70mL, mismatch ratio\>1.2, mismatch volume \>10mL). The eligible patients will be randomly assigned to receive endovascular treatment (EVT) +best medical treatment or best medical treatment within 24 hours after the time that the patient was last known to be well (including after stroke on awakening and unwitnessed stroke). The primary outcome is the proportion of patients with an mRS score ≤ 1 at 90 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
568
EVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.
Administration of BMT should be done according to routine clinical practice and current international guidelines. Administration of BMT must not be delayed by randomisation and should be done independently from participation in this trial.
Beijing tiantan hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Daxing District People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGXingtang County People's Hospital
Longzhou, Hebei, China
The proportion of patients who have a score of 0 or 1 on the modified Rankin Scale (mRS) at 90 days
The proportion of patients with an mRS score ≤ 1 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
Time frame: 90 days
Ordinal distribution of modified Rankin Scale (mRS) at 90 days
Ordinal distribution of mRS at 90 days (shift analysis). The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
Time frame: 90 days
The proportion of patients with an modified Rankin Scale (mRS) score of 0-2 at 90 days
The proportion of patients with an mRS score of 0-2 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
Time frame: 90 days
The rate of early neurological improvement at 24 hours
The rate of early neurological improvement at 24 hours after randomization (defined as a National Institute of Health Stroke Scale \[NIHSS\] score ≤1 or ≥4 points compared with the baseline)
Time frame: 24 hours
The proportion of patients with an modified Rankin Scale (mRS) score of 5-6 at 90 days
The proportion of patients with an mRS score of 0-2 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
Time frame: 90 days
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Luoyang Yiluo Hospital
Luoyang, Henan, China
RECRUITINGPeople's Hospital of Queshan
Panlong, Henan, China
RECRUITINGChangle People's Hospital
Changle, Shandong, China
RECRUITINGThe median value of EuroQol 5-Dimension (EQ-5D) index
EuroQol 5-Dimension (EQ-5D) index at 90 days and 1 year. The EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) is a standardized instrument for the measurement of health status. The domains mobility, self-care, everyday activity, pain or physical discomfort, and fear or depression are assessed on a five-point scale, with 1 indicating no problem in this domain and 3 indicating extreme problems. The visual analogue scale ranges from 0 to 100, with 0 indicating the worst health imaginable and 100 the best health imaginable.
Time frame: 90 days and 1 year
Ordinal distribution of modified Rankin Scale (mRS) at 1 year
Ordinal distribution of modified Rankin Scale (mRS) at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
Time frame: 1 year
The proportion of symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage within 24 hours (as defined by Heidelberg criteria)
Time frame: 24 hours
The proportion of all-cause mortality
All-cause mortality at 90 days and 1 year
Time frame: 90 days and 1 year
The proportion of systematic bleeding
Moderate or severe systemic bleeding is defined according to the criteria established in the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial
Time frame: 90 days
The proportion of serious adverse events (SAEs)
serious adverse events within 90 days
Time frame: 90 days