Evaluating endovascular treatment for medium vessel occlusion strokes

Evaluation of Endovascular Treatment in Acute Intracranial Distal Medium Vessel Occlusion Stroke - a Multicenter, Randomized Controlled, Clinical Trial

This study is testing a new treatment called endovascular therapy for people who have had strokes caused by medium vessel blockages to see if it works better than regular care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 564 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of University of Science and Technology of China (Academic / other)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06146790 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of endovascular treatment (EVT) for patients suffering from acute ischemic strokes caused by distal medium vessel occlusions. Given that these occlusions account for a significant portion of strokes and often lead to severe disability, the study seeks to provide a novel treatment approach compared to standard medical management. Participants will be randomized to receive either EVT or standard care, with the goal of determining which method yields better outcomes. The study is motivated by previous non-randomized studies suggesting that EVT may be effective for these types of strokes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed distal medium vessel occlusion and significant clinical deficits.

Not a fit: Patients with strokes secondary to proximal vessel occlusions or those with severe premorbid disabilities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with medium vessel occlusion strokes.

How similar studies have performed: Previous non-randomized studies have shown promising results for endovascular treatment in similar cases, indicating potential for success in this randomized trial.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years (no upper age limit).
2. Evidence of a primary (e.g., not secondary to EVT of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the co/non-dominant M2 segment\* or M3 segment of the MCA, the ACA (A1, A2, or A3 segments), or the PCA (P1, P2 or P3 segments) resulting in significant clinical deficits and expected to be treatable by endovascular thrombectomy.

   \* Co/non-dominant M2 segment vessel diameter should not exceed 2.0 mm. Co-dominant supplying 50% of the MCA territory vs non-dominant supplying \<50% of the MCA territory.
3. Premorbid mRS ≤ 2.
4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6 at the time of randomization.
5. Time from onset (or time last seen well) to randomization\<24 hours.
6. For patients with more than 6 hours of onset (or time last seen well), Clinical-Imaging mismatch assessment defined as any of the following scenarios (A or B):

   A. Non-contrast CT of the head or Brain MRI DWI lesion with \<50% involvement of the vascular territory corresponding to the clinical manifestation:

   B. Target Mismatch Profile on CT perfusion or MRI (Mismatch Volume \>10cc and mismatch Ratio \>1.4 ).
7. Informed consent obtained from patient or acceptable patient surrogate.

Exclusion Criteria:

1. Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH).
2. Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of \<6 at randomization.
3. Significant ischemic changes in a territory other than the occluded site that in the opinion of the investigator could reduce the benefit of endovascular treatment.
4. Contra indication to imaging with MR or CT with contrast agents.
5. Any terminal illness such that patient would not be expected to survive more than 1 year.
6. Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other than meningioma.
7. Any imaging findings suggestive of futile recanalization in the judgment of the local investigator.
8. seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS.
9. Baseline blood glucose of \<50 mg/dL (2.78 mmol) or \>400 mg/dL (22.20 mmol).
10. Known history of hereditary or acquired hemorrhagic diathesis and/or platelet count \<50×109/L.
11. Known renal failure as defined as serum creatinine levels \> 260umol/l（3.0 mg/dL）.
12. Presumed septic embolus or suspicion of bacterial endocarditis.
13. Any other condition that, in the opinion of the investigator could impose hazards to the patient or affect the participation of the patient in the study if an endovascular procedure was performed.
14. History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
15. Subjects with occlusions in multiple vascular territories (e.g., bilateral or multi-territorial anterior circulation, or anterior/posterior circulation)
16. Subject participating in a study involving an investigational drug or device that would impact this study.
17. Known pregnancy.
18. Prisoner or incarceration

Where this trial is running

Hefei, Anhui

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Wei Hu, MD, PhD

Conditions Acute Ischemic Stroke; Endovascular Thrombectomy; Medium Vessel Occlusion; Stroke Due To Medium Vessel Occlusion; Endovascular Treatment; Standard Medical Management