Endovascular Treatment for Stroke Post 1 Day （24 Hours）

NCT06580730 | Not Yet Recruiting

• 1 other identifier: ETP-1
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

Acute ischemic stroke (AIS) is one of the leading causes of disability and mortality worldwide. The treatment of this condition is time-critical, with the key to effective therapy being the early recanalization of the occluded vessel and restoration of blood flow to salvage the ischemic penumbra tissue. Currently, the time window for endovascular treatment in the anterior circulation can be extended up to 24 hours. Exploring endovascular treatments for patients beyond this time window (from 24 hours to 30 days) could mean hope for a greater number of AIS patients.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90

  Modified Rankin Scale：1. Total asymptomatic score 0 2, despite symptoms, but no obvious dysfunction, can complete all daily work and life score 1 Mildly disabled, unable to complete all pre-illness activities, but able to take care of daily tasks without assistance score 2 3, moderate disability, need some help, but can walk independently score 3 4, moderate to severe disability, can not walk independently, daily life needs help from others score 4 5, severe disability, bed rest, urinary incontinence, daily life completely dependent on others score 5 6. Death score 6

  90days

Secondary Outcomes (18)

• Proportion of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence

  90days

• Sustained vessel recanalization rate at 90 days

  90days

• Assessment of activities of daily living at 90 days

  90days

• Proportion with "early improvement" between day 2-7 post-randomization/discharge

  2-7days

• Difference in median infarct volume size at 24 (-6/+24) hours post-randomization

  24hours

Study Arms (2)

Test group

EXPERIMENTAL

Endovascular treatment combined with standard medical treatment

Procedure: Endovascular treatment

Control group

OTHER

Standard medical treatment

Other: Standard medical treatment

Interventions

Endovascular treatment PROCEDURE

Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.

Also known as: mechanical revascularization

Test group

Standard medical treatment OTHER

Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 and ≤80
• Baseline NIHSS ≥ 6 and maintained ≥ 6 before randomization
• Stroke onset or more than 24 hours from the last known well state and within 30 days.
• Pre-stroke mRS score of 0 or 1 points
• The subject or their legally authorized representative has signed the informed consent form for the study
• Magnetic Resonance Angiography (MRA), Computed Tomography Angiography (CTA), or Digital Subtraction Angiography (DSA) confirms the occlusion of major intracranial vessels (occlusion of the internal carotid artery and/or the middle cerebral artery M1/M2 segment)
• Meets one of the following imaging evaluation criteria:
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• Assessed by Computed Tomography Perfusion (CTP) or Perfusion Weighted Imaging (PWI) with MRI: Infarct core volume is less than 100 mL and the mismatch ratio is ≥1.2 or the mismatch volume is ≥10 mL.
• Clinical imaging mismatch is defined by MR-DWI or CTP-rCBF images as:
• Infarct volume is less than 30 mL and NIHSS score is ≥10;
• Infarct volume is between 30 mL and 100 mL and NIHSS score is ≥20

You may not qualify if:

• In the judgment of the clinician responsible for treatment, it is considered unlikely to benefit from the trial (e.g., advanced dementia, severe pre-stroke disability (mRS ≥2), high likelihood of early death)
• Major comorbidities that may interfere with the assessment of results and follow-up (e.g., severe heart failure, renal failure, etc.)
• Rapid improvement in neurologic status to NIHSS\<6 or evidence of vascular reconstruction before randomization
• Uncontrolled seizures at the time of stroke onset that, if preventing the acquisition of an accurate baseline NIHSS
• Baseline platelet count\<50,000/uL
• Severe persistent hypertension (systolic blood pressure \>220 mmHg or diastolic blood pressure\>120 mmHg)
• Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an International Normalized Ratio (INR) \>3
• Suspected septic emboli, suspected bacterial endocarditis
• Known allergy to iodine, heparin, anesthetics, or other clear contraindications to the endovascular treatment procedure
• Pregnant women
• Other serious, progressive, or terminal illnesses (as judged by the investigator) or life expectancy of less than 6 months
• Attempt to use a neurothrombectomy device to remove the blood clot before randomization
• Currently participating in other studies of investigational drugs or devices
• Any other conditions that, in the opinion of the investigator, would impede endovascular surgery or pose a significant risk to the subject during endovascular surgery
• Intracranial hemorrhage, including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and epidural/subdural hemorrhage;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hubo, Doctor

CONTACT

+86 13707114863; hubo@mail.hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 24, 2024
• First Posted: August 30, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)