NCT06155032

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

Study of Rescue Endovascular Therapy for Progressive Acute Mild Ischemic Stroke With Large Vascular Occlusion--- A Multi-centered, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial (RESCUE END-LOW)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: First Affiliated Hospital of Wannan Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The RESCUE END-LOW is a multicentered, prospective, randomized, open-label, blinded end-point (PROBE) study. A total of approximately 272 patients (age ≥ 18 years) in a late window (\>24 hours) with a minor stroke (NIHSS \<6) who experienced an END and the imaging evidence of an occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content. One group will receive best medical management alone the other group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting. The primary objective is to establish the efficacy of EVT in a late window for patients with LVO and a minor stroke who have experienced an END. The study consists of seven visits including the day of randomization, 24 hours after randomization, 48 hours, 72 hours, 7 days or discharge, and 30 and 90 days. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The primary endpoint is the rate of modified Rankin's scale (mRS) 0-2 at 90 days. The trial is anticipated to last from December 2023 to December 2025 with 272 subjects recruited form about 30 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Yijishan Hospital, Wannan Medical College.

Conditions

• Stroke, Ischemic
• Cerebrovascular; Disorder, Occlusive

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-04
• Primary completion: 2026-03-31
• Completion: 2026-06-30
• First posted: 2023-12-04
• Last updated: 2025-09-12

Locations

7 sites across 1 country: China