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

NCT06155032 | Recruiting DMC

• 1 other identifier: 20230004
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

endovascular therapy; mild stroke; neurological deterioration

Outcome Measures

Primary Outcomes (1)

• 90-day good clinical outcome

  Good clinical outcome defined as a dichotomized mRS 0-2 outcome

  90±7 days after randomization

Secondary Outcomes (8)

• Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard

  within 24±6 hours after randomization

• Neurofunctional deficit defined as modified Rankin Scale (mRS)

  90±7 days after randomization

• 90-day clinical outcome

  90±7 days after randomization

• Change of infarct volume from baseline to 7 days

  baseline, 7 days after randomization

• All-cause mortality rate

  90±7 days after randomization

Study Arms (2)

Endovascular therapy

EXPERIMENTAL

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.

Procedure: Endovascular therapy

Best medical management

ACTIVE COMPARATOR

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.

Procedure: Endovascular therapy; Drug: Best medical management

Interventions

Endovascular therapy PROCEDURE

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.

Also known as: EVT group

Best medical management; Endovascular therapy

Best medical management DRUG

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

Also known as: Best medical management group

Best medical management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Pre-stroke mRS score \>1;
• Imaging confirms the progression of symptoms caused by intracranial hemorrhage, brain edema, or other clear causes;
• The target vessel may have factors that may prevent it from completing endovascular treatment, such as a diameter less than 1.5mm, a tortuous vascular pathway, difficulty in reaching the target position with instruments, or difficulty in recovery;
• Severe stenosis or occlusion of multiple blood vessels;
• Combined with untreated intracranial aneurysms, intracranial tumors (excluding small meningiomas), or intracranial vascular malformations;
• Intracranial hemorrhage within 6 months, including cerebral parenchymal hemorrhage, ventricular hemorrhage, and subarachnoid hemorrhage;
• Have had gastrointestinal or urinary system bleeding, acute myocardial infarction, traumatic brain injury, or undergone major surgical procedures within the past month;
• Known hemorrhagic tendency (including but not limited to): Baseline platelet count \<40×109/L; on anticoagulant therapy with warfarin and International Normalized Ratio (INR) \> 2 (Patients with no history or suspected coagulopathy do not need to wait for laboratory results of INR or APTT prior to enrollment) Severe heart, liver, kidney function damage or other severe late stage diseases of the system;
• Known allergies to treatment related drugs such as iodine contrast agents, etc; Known severe allergy (more than a rash) to contrast media uncontrolled by medications;
• Refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg);
• Uncontrolled blood sugar abnormalities (less than 2.8mmol/l or greater than 22.2mmol/l);
• Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test;
• The expected survival time is less than 1 year (such as complicated with malignant tumor, serious heart and lung diseases, etc.)
• Participation in other interventional randomized clinical trials that may confound outcome assessment of the trial
• Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders)

Sponsors & Collaborators

• Xiangtan Central Hospital: collaborator
• The First Affiliated Hospital of Hainan Medical University: collaborator
• Huang Shan People's Hospital: collaborator
• Fuyang people's hospital: collaborator
• Linyi People's Hospital: collaborator
• Jiujiang No.1 People's Hospital: collaborator
• Taihe Hospital: collaborator
• First Affiliated Hospital of Wannan Medical College: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator

Study Sites (7)

Fuyang People's Hospital

Fuyang, Anhui, China

RECRUITING

First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230001, China

RECRUITING

The first Hospital of Anhui University Of Science & Technology

Huainan, Anhui, China

RECRUITING

Huangshan City People's Hospital

Huangshan City, Anhui, China

RECRUITING

Wan Bei General Hospital of Wanbei Coal power Group

Suzhou, Anhui, China

RECRUITING

The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

RECRUITING

Xiangyang No.1 People's Hospital

Xiangyang, Hubei, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Bites and Stings

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Zhiming Zhou, PhD

  The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College

  PRINCIPAL INVESTIGATOR

• Kai Wang, PhD

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiming Zhou, PhD

CONTACT

(++)86-(+)-553-5739543; neuro_depar@hotmail.com

Kai Wang, PhD

CONTACT

wangkai1964@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Drug: Best medical management Procedure: Endovascular therapy

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 4, 2023
• Study Start: January 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)