Status:
RECRUITING
Evaluation of Endovascular Treatment in Acute Intracranial Distal Medium Vessel Occlusion Stroke
Lead Sponsor:
The First Affiliated Hospital of University of Science and Technology of China
Conditions:
Acute Ischemic Stroke
Endovascular Thrombectomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale: Distal Medium Vessel Occlusion (MeVO) are thought to cause as many as 25% to 40% of all acute ischemic strokes (AIS). Despite their relatively high frequency, there is no consensus regardin...
Eligibility Criteria
Inclusion
- Age ≥18 years (no upper age limit).
- 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.
- Premorbid mRS ≤ 2.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6 at the time of randomization.
- Time from onset (or time last seen well) to randomization\<24 hours.
- 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 ).
- Informed consent obtained from patient or acceptable patient surrogate.
Exclusion
- Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH).
- 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.
- 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.
- Contra indication to imaging with MR or CT with contrast agents.
- Any terminal illness such that patient would not be expected to survive more than 1 year.
- Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other than meningioma.
- Any imaging findings suggestive of futile recanalization in the judgment of the local investigator.
- seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS.
- Baseline blood glucose of \<50 mg/dL (2.78 mmol) or \>400 mg/dL (22.20 mmol).
- Known history of hereditary or acquired hemorrhagic diathesis and/or platelet count \<50×109/L.
- Known renal failure as defined as serum creatinine levels \> 260umol/l（3.0 mg/dL）.
- Presumed septic embolus or suspicion of bacterial endocarditis.
- 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.
- History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Subjects with occlusions in multiple vascular territories (e.g., bilateral or multi-territorial anterior circulation, or anterior/posterior circulation)
- Subject participating in a study involving an investigational drug or device that would impact this study.
- Known pregnancy.
- Prisoner or incarceration
Key Trial Info
Start Date :
December 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
564 Patients enrolled
Trial Details
Trial ID
NCT06146790
Start Date
December 14 2023
End Date
March 1 2026
Last Update
September 5 2024
Active Locations (1)
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1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China, 230001