Endovascular Treatment for Stroke Post 1 Day （24 Hours）

NCT ID: NCT06580730

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test group

Endovascular treatment combined with standard medical treatment

Group Type: EXPERIMENTAL

Endovascular treatment

Intervention Type: 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.

Control group

Standard medical treatment

Group Type: OTHER

Standard medical treatment

Intervention Type: OTHER

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

Interventions

Endovascular treatment

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.

Intervention Type: PROCEDURE

Standard medical treatment

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

Intervention Type: OTHER

Other Intervention Names

mechanical revascularization

Eligibility Criteria

Inclusion Criteria

1. Age≥18 and ≤80

2. Baseline NIHSS ≥ 6 and maintained ≥ 6 before randomization

3. Stroke onset or more than 24 hours from the last known well state and within 30 days.

4. Pre-stroke mRS score of 0 or 1 points

5. The subject or their legally authorized representative has signed the informed consent form for the study

1. 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)

2. Meets one of the following imaging evaluation criteria:

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1. 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.

2. Clinical imaging mismatch is defined by MR-DWI or CTP-rCBF images as:

1. Infarct volume is less than 30 mL and NIHSS score is ≥10;

2. Infarct volume is between 30 mL and 100 mL and NIHSS score is ≥20

Exclusion Criteria

1. 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)

2. Major comorbidities that may interfere with the assessment of results and follow-up (e.g., severe heart failure, renal failure, etc.)

3. Rapid improvement in neurologic status to NIHSS<6 or evidence of vascular reconstruction before randomization

4. Uncontrolled seizures at the time of stroke onset that, if preventing the acquisition of an accurate baseline NIHSS

5. Baseline platelet count<50,000/uL

6. Severe persistent hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure>120 mmHg)

7. Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an International Normalized Ratio (INR) >3

8. Suspected septic emboli, suspected bacterial endocarditis

9. Known allergy to iodine, heparin, anesthetics, or other clear contraindications to the endovascular treatment procedure

10. Pregnant women

11. Other serious, progressive, or terminal illnesses (as judged by the investigator) or life expectancy of less than 6 months

12. Attempt to use a neurothrombectomy device to remove the blood clot before randomization

13. Currently participating in other studies of investigational drugs or devices

14. 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

1. Intracranial hemorrhage, including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and epidural/subdural hemorrhage;

2. Evidence of intracranial tumors as shown by CT or MRI (except for small meningiomas);

3. CTA/MRA showing excessive tortuosity of the cervical vessels, which may hinder endovascular treatment;

4. Suspected aortic dissection based on medical history and CTA/MRA;

5. Presence of an intracranial stent in the same vascular area, which would impede the smooth progress of surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Hu Bo

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, , China

Countries

China

Central Contacts

Hubo, Doctor

Role: CONTACT

hubo@mail.hust.edu.cn

+86 13707114863

Other Identifiers

ETP-1

Identifier Type: -

Identifier Source: org_study_id