NCT05885178

Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-1 (TRACK-LVO-1)

Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-1 (TRACK-LVO-1): an Imaging-based Patient Registry Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Tianjin Huanhu Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to establish an academic, real-world, single-center, observational registry of consecutive patients hospitalized with acute ischemic stroke (AIS) due to large vessel occlusions (LVO), treated with either endovascular therapy (EVT) or best medical management (BMM).

Detailed description

Stroke is a major threat to public health and is exacerbating socioeconomic development. It is the leading cause of mortality among residents in China. Large vessel occlusion (LVO) is a predictor of unfavorable outcomes and can account for up to 52% of patients with acute ischemic stroke (AIS). The definition of LVO and its optimal screening imaging modalities remain controversial. In this registry, the investigators defined LVO as an occlusion of the intracranial ICA with or without the involvement of the terminal bifurcation, M1 and/or M2 segment of the MCA, A1 and/or A2 segment of the ACA, VA, BA, or P1 and/or P2 segment of the PCA. TRACK-LVO is an academic, real-world, single-center, observational registry, in which consecutive patients hospitalized with AIS due to LVO will be treated with either EVT or BMM. Baseline information and clinical follow-up information at 90 days from stroke onset are collected. The key baseline items in this registration for both EVT and BMM groups include basic demographic profiles, past medical history, NIHSS score, treatment with intravenous alteplase, type of stroke onset, time from stroke onset to admission/imaging, imaging characteristics such as the volume of the ischemic core and occlusion site, and treatment-related complications. Additional information collected in EVT groups includes details of EVT procedure and angiographic images. The investigators enrolled patients with LVO screened under different imaging modalities to further reveal the optimal imaging modalities in the detection of LVO. The investigators also tend to compare the prognosis of AIS patients with LVO receiving endovascular therapy and the best medical management respectively.

Conditions

• Stroke, Acute Ischemic
• Endovascular Procedures
• Large Vessel Occlusion

Interventions

Type	Name	Description
PROCEDURE	Endovascular Therapy	Endovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices.

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-11-01
• Completion: 2025-01-01
• First posted: 2023-06-01
• Last updated: 2023-11-29

Locations

1 site across 1 country: China