Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography

Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography: A Multicentre, Open-label, Registry-linked, Randomised Controlled Trial

The goal of this clinical trial is to investigate if endovascular treatment (EVT) can effectively treat patients with large vessel occlusion (LVO) who present beyond the typical 24-hour window after symptom onset. The main questions it aims to answer are:

• Can EVT improve functional independence at 90 days for patients treated after 24 hours?
• What is the safety profile of EVT in this delayed treatment group compared to best medical management (BMM)? Researchers will compare EVT outcomes in patients presenting after 24 hours to those receiving BMM to see if EVT offers significant benefits.

Participants will:

• Receive either EVT or BMM based on their eligibility.
• Undergo CT angiography to assess collateral circulation and to confirm the presence of LVO.
• Be followed for 90 days to evaluate functional outcomes and safety measures.

Study Overview

• Status: Recruiting
• Conditions: Large Vessel Occlusion; Thrombectomy; Stroke Acute; Medical Treatment
• Intervention / Treatment: Procedure: Endovascular Thrombectomy

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Wei, MD, PhD; Phone Number: 13502182903; Email: drweiming@163.com
• Study Contact Backup: Name: Yongbo Xu, MD; Phone Number: 17361616533; Email: yonbur@outlook.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300070
      • Recruiting
      • Tianjin Huanhu Hospital
      • Principal Investigator: Ming Wei, MD, PhD
      • Contact: Ming Wei, MD, PhD; Phone Number: 022-13502182903; Email: drweiming@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Confirmation of ICA or MCA-M1 occlusion, as detected by MRA or CTA, with carotid occlusions potentially occurring in either the cervical or intracranial regions, and the possibility of accompanying tandem MCA lesions.
2. Demonstration of moderate to good collateral flow, as evidenced by CTA imaging.
3. The patient must be aged 18 years or older.
4. The baseline NIHSSS score is equal to or greater than 2, and this score remains equal to or greater than 2 immediately prior to randomization.
5. Endovascular treatment can be initiated (via femoral puncture) within a window of 24 to 72 hours from the onset of the stroke. The onset of the stroke is defined as the time the patient was last known to be at their neurologic baseline (patients with wake-up strokes are eligible if they meet the aforementioned time constraints).
6. There must be no significant pre-stroke disability, as indicated by a pre-baseline modified Rankin Scale score of 0-2.
7. The patient must be willing and able to return for the protocol-required follow-up visits.
8. The patient or their legally authorized representative must have signed the Informed Consent form.

Exclusion Criteria:

1. The subject has a serious, advanced, or terminal illness (as determined by the investigator) or a life expectancy of less than six months.
2. The subject has a pre-existing medical, neurological, or psychiatric disease that would interfere with neurological or functional evaluations, or is already participating in another drug or device study.
3. The subject is pregnant.
4. The subject has contraindications for both MRI and CT contrast that prevent an MRI or CT contrast perfusion study. The hospital's local standard criteria should be applied to determine if contraindications exist.
5. The subject has a known allergy to iodine and has previously been refractory to pretreatment medications.
6. The subject has been treated with tPA more than 4.5 hours after the last known well time.
7. The subject has a known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or has recently undergone oral anticoagulant therapy with an INR greater than 3.
8. The subject has symptoms consistent with stroke in multiple locations.
9. The subject has seizures at stroke onset, which makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
10. The subject has a baseline blood glucose level of less than 50mg/dL (2.78 mmol) or greater than 400mg/dL (22.20 mmol).
11. The subject has a baseline platelet count of less than 50,000/uL.
12. The subject has severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg) that is not treatable with medications.
13. The subject is currently participating in another investigational drug or device study or registry.
14. The subject is presumed to have a septic embolus, suspicion of bacterial endocarditis, or cerebral vasculitis.
15. The subject has had clot retrieval attempted using a neurothrombectomy device within 24 hours of symptom onset.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endovascular thrombectomy	Procedure: Endovascular Thrombectomy; Endovascular thrombectomy (EVT) in this clinical trial involves the mechanical removal of a thrombus from a blocked large cerebral artery using specialized devices like stent retrievers or aspiration catheters. Key distinguishing features of this EVT protocol include: Extended Time Window: Unlike standard EVT, which is typically performed within 24 hours after symptom onset, this intervention targets patients presenting beyond 24 hours.; Collateral Circulation Assessment: Multi-phase CT angiography (CTA) is employed to evaluate collateral flow, prioritizing patients with favorable collateral grades. This selection process helps ensure the identification of patients most likely to benefit from EVT despite the late presentation.
No Intervention: Best Medical Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Rankin Scale	a 7-point scale ranging from 0 (no symptoms) to 6 (death)	90 days (± 14 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
extended treatment in cerebral ischemia (eTICI) score	during EVT procedure
recanalization rate	24 hours after randomization, assessed using Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA)
score on the NIHSS	24 hours after randomization, 5 to 7 days after randomization, or at discharge, whichever occurs first
final infarct volume on MRI	24 hours after randomization on MRI
dichotomized mRS score of 0-1 vs 2-6	at 90 days
dichotomized mRS score of of 0-2 vs 3-6	at 90 days
dichotomized mRS score of 0-3 vs 4-6	at 90 days
death	at 90 days
Score on the Barthel Index	at 90 days
Score on the EQ-5D-5L	at 90 days

Collaborators and Investigators

• Sponsor: Tianjin Huanhu Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: CTA; Acute Ischemic Stroke; Endovascular Thrombectomy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: tjhh202410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No