The primary hypothesis being tested in this trial is that acute ischemic stroke with isolated internal carotid artery occlusion will have improved clinical outcomes when given early endovascular treatment compared with that of given best medical treatment.
Stroke is the leading cause of death and disability among Chinese residents, and ischemic stroke accounts for 70-80% of all strokes. Isolated internal carotid artery occlusion (iICAO) refers to occlusion of the internal carotid artery, which is not involve the circle of Willis, the M1 and the proximal M2 segment of the middle cerebral artery. IICAO accounts for about 20-25% of symptomatic acute internal carotid artery occlusion. Previous studies have shown that despite the best medical treatment, including intravenous thrombolysis, the early recanalization rate of patients with acute iICAO is only 4.4%-23%, and less than half of the patients eventually achieve self-care. Endovascular Treatment (EVT) is the most effective reperfusion therapy for large vessel occlusive stroke. Since only a few retrospective studies have reported the efficacy and safety of early EVT in patients with acute iICAO stroke, there is a lack of high-level prospective evidence so far. Therefore, the aim of this study is to conduct a prospective, multicenter, open-label, randomized controlled clinical trial to evaluate the efficacy and safety of early EVT in patients with acute iICAO stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Endovascular treatment could be performed with any recanalization strategy, such as thrombectomy with aspiration or stent and angioplasty with balloon dilation or stent implantation, depending on the operator's choice and anatomical and radiological circumstances. In the setting of emergency stenting, the use of antiplatelet agents will depend on operator preference, anatomy, and bleeding risk.
Medical treatment includes intravenous thrombolysis, anticoagulant or antiplatelet drugs, etc. which is determined by the attending physician according to the Chinese guidelines or expert consensus.
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
RECRUITINGGood clinical outcome
Score in modified Rankin Scale (mRS) ≤ 2
Time frame: 90(±14)days after randomization
National Institute of Health Score Scale (NIHSS)
Time frame: 24(-6/+12)hours after randomization
Recanalization rate of internal carotid artery
Time frame: 24(-6/+12)hours and 90(±14)days after randomization
Early neurologic improvement
The NIHSS score of 0-2 at 24 hours or a decrease of ≥8 points from baseline
Time frame: 24 hours after randomization
Early neurological deterioration
The NIHSS score at 24 hours or on 5-7 days increased by ≥4 points from baseline
Time frame: 24 hours or 5-7 days after randomization
Mortality
All-cause mortality
Time frame: 90 days after randomization
Symptomatic intracranial hemorrhage
Time frame: 24(-6/+12)hours after randomization
Procedural/device-related adverse events
Time frame: 30(±5)days after randomization
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