Stopped: Following the interim analysis, the planned number of staff (208) will not be sufficient to achieve the main objective
Rationale: Acute large-vessel strokes, requiring endovascular treatment, are currently being managed through radiology department before being transferred to the angiography room. However, patients with severe neurological deficit have demonstrated even greater benefits from recanalization as the symptom onset-to-reperfusion time is shortened to less than 1 hour. Recent pilot study have shown a benefit in reducing management delays with direct admission to the angiography room and subsequently in increasing functional independence at 3 months. Therefore, the aim is to demonstrate the superiority of the direct angio-suite transfer versus the standard management, in terms of 3-month functional independence, in patients strongly suspected of having a severe ischemic stroke related to acute large-vessel occlusion of the anterior circulation, and treated by mechanical thrombectomy ± intravenous thrombolysis. Methods and Design: The DIRECT ANGIO trial is a (PROBE) randomized, multicenter, controlled, open-label, blinded endpoint clinical trial. Study Outcomes: The primary outcome is the rate of patients with 3-month functional independence defined as modified Rankin Scale score ≤2 at 3 months.
Age range
18 Years – 85 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
3-month functional independence
Timeframe: 3 months (±15 days)