Rescue Endovascular Therapy for Progressive Acute Mild Ischemic Stroke With Large Vascular Occlusion

Summary

Endovascular therapy (EVT) added on best medical management is currently recommended in acute large vascular occlusion (LVO) stroke patients with National Institutes of Health Stroke Scale (NIHSS) score \>5. Thus, a sizeable fraction of patients with a minor stroke that do not undergo cerebrovascular screening may experience an early neurological deterioration (END) due to LVO, possibly leading to poor long-term functional outcome. However, whether these patients may still benefit from a rescue EVT is unknown, especially in a late window (\>24 hours). In this study, the investigators assume that best medical management plus EVT might be superior than best medical management alone in a late window for minor stroke patients who have experienced an LVO and END. The primary objective of the study was to establish the safety and efficacy of EVT in a late window for minor stroke patients in the anterior circulation who experienced an LVO and END.

Conditions

• Stroke, Ischemic
• Cerebrovascular; Disorder, Occlusive

Interventions

PROCEDURE

Endovascular therapy

Patients in this group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting. In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment.

DRUG

Best medical management

All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Xiangtan Central Hospital

  collaborator OTHER

• The First Affiliated Hospital of Hainan Medical University

  collaborator OTHER_GOV

• Huang Shan People's Hospital

  collaborator OTHER

• Fuyang people's hospital

  collaborator OTHER

• Linyi People's Hospital

  collaborator OTHER

• Jiujiang No.1 People's Hospital

  collaborator OTHER

• Taihe Hospital

  collaborator OTHER

• First Affiliated Hospital of Wannan Medical College

  lead OTHER

Principal Investigators

• Zhiming Zhou, PhD · The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College

• Kai Wang, PhD · The First Affiliated Hospital of Anhui Medical University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-04

Primary Completion

2026-12-31

Completion

2027-03-30

Countries

• China

Study Locations