NCT07016854

Early Endovascular Treatment in Isolated Internal Carotid Artery Occlusion

Evaluation of Early Endovascular Treatment in Acute Ischemic Stroke With Isolated Internal Carotid Artery Occlusion (EVT-iICAO)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stroke, Acute Ischemic

Interventions

Type	Name	Description
PROCEDURE	Endovascular treatment	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.
DRUG	The best medical treatment	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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-06-12
• Last updated: 2025-06-12

Locations

1 site across 1 country: China