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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular treatment plus the best medical treatment | Experimental |
| |
| The best medical treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Good clinical outcome | Score in modified Rankin Scale (mRS) ≤ 2 | 90(±14)days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| National Institute of Health Score Scale (NIHSS) | 24(-6/+12)hours after randomization | |
| Recanalization rate of internal carotid artery | 24(-6/+12)hours and 90(±14)days after randomization | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| The best medical treatment | Drug | 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. |
|
| Early neurologic improvement |
The NIHSS score of 0-2 at 24 hours or a decrease of ≥8 points from baseline |
| 24 hours after randomization |
| Early neurological deterioration | The NIHSS score at 24 hours or on 5-7 days increased by ≥4 points from baseline | 24 hours or 5-7 days after randomization |
| Mortality | All-cause mortality | 90 days after randomization |
| Symptomatic intracranial hemorrhage | 24(-6/+12)hours after randomization |
| Procedural/device-related adverse events | 30(±5)days after randomization |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |