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
Location: See all (7) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years;

• Presenting with symptoms consistent with an AIS and the initial NIHSS score \<6 points;

• Symptom progression within 7 days of first onset;

• Randomization can be finished \> 24 hours of stroke onset (stroke onset time is defined as last known well time);

• Symptom progression to randomization time ≤ 24 hours;

• NIHSS score before randomization ≥ 6 points;

• Informed consent signed.

⁃ Specific Neuroimaging Inclusion Criteria

• CTA or MRA proved occlusion of Internal Carotid Artery (ICA) terminal or M1 segment of Middle Cerebral Artery;

• The progression of symptoms is caused by the recurrence of cerebrovascular diseases in the same vascular region, or the pathogenesis is caused by reduced blood flow perfusion;

• NCCT ASPECTS before randomization ≥ 6

• CTP or MRP assessment shows low perfusion in the target vessel area, and meets the following criteria: core infarction volume is less than 50ml, mismatch rate is greater than or equal to 1.8, and mismatch volume is greater than 15ml.

Locations
Other Locations
China
Fuyang People's Hospital
RECRUITING
Fuyang
First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
The first Hospital of Anhui University Of Science & Technology
RECRUITING
Huainan
Huangshan City People's Hospital
RECRUITING
Huangshan City
Wan Bei General Hospital of Wanbei Coal power Group
RECRUITING
Suzhou
The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College
RECRUITING
Wuhu
Xiangyang No.1 People's Hospital
RECRUITING
Xiangyang
Contact Information
Primary
Zhiming Zhou, PhD
neuro_depar@hotmail.com
(++)86-(+)-553-5739543
Backup
Kai Wang, PhD
wangkai1964@126.com
Time Frame
Start Date: 2024-01-04
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 272
Treatments
Experimental: 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.
Active_comparator: Best medical management
Patients in this group will receive best medical management alone. 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.
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Wannan Medical College
Collaborators: Huang Shan People's Hospital, Xiangtan Central Hospital, The First Affiliated Hospital of Anhui Medical University, Jiujiang No.1 People's Hospital, Taihe Hospital, Linyi People's Hospital, The First Affiliated Hospital of Hainan Medical University, Fuyang people's hospital

This content was sourced from clinicaltrials.gov