NCT06654375

Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography

Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography: A Multicentre, Open-label, Registry-linked, Randomised Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Tianjin Huanhu Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate if endovascular treatment (EVT) can effectively treat patients with large vessel occlusion (LVO) who present beyond the typical 24-hour window after symptom onset. The main questions it aims to answer are: * Can EVT improve functional independence at 90 days for patients treated after 24 hours? * What is the safety profile of EVT in this delayed treatment group compared to best medical management (BMM)? Researchers will compare EVT outcomes in patients presenting after 24 hours to those receiving BMM to see if EVT offers significant benefits. Participants will: * Receive either EVT or BMM based on their eligibility. * Undergo CT angiography to assess collateral circulation and to confirm the presence of LVO. * Be followed for 90 days to evaluate functional outcomes and safety measures.

Conditions

• Stroke Acute
• Thrombectomy
• Medical Treatment
• Large Vessel Occlusion

Interventions

Type	Name	Description
PROCEDURE	Endovascular Thrombectomy	Endovascular thrombectomy (EVT) in this clinical trial involves the mechanical removal of a thrombus from a blocked large cerebral artery using specialized devices like stent retrievers or aspiration catheters. Key distinguishing features of this EVT protocol include: * Extended Time Window: Unlike standard EVT, which is typically performed within 24 hours after symptom onset, this intervention targets patients presenting beyond 24 hours. * Collateral Circulation Assessment: Multi-phase CT angiography (CTA) is employed to evaluate collateral flow, prioritizing patients with favorable collateral grades. This selection process helps ensure the identification of patients most likely to benefit from EVT despite the late presentation.

Timeline

• Start date: 2024-06-25
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-10-23
• Last updated: 2024-10-23

Locations

1 site across 1 country: China