Study of Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients With a Large Infarct Core

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Endovascular therapy (EVT) was recommended as the primary treatment for patients with acute large vascular occlusion (LVO) in anterior circulation. However, the evidences of EVT for patients with large infarct volume were limited. In this study, the investigators assume that best medical management plus EVT might be superior than best medical management alone for patients who have evidence of a large infarct volume. The primary objective of the study was to establish the safety and efficacy of EVT in patients presenting with symptoms of acute ischemic stroke (AIS) from LVO in the anterior circulation and having a large infarct volume.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital

Criteria

Inclusion Criteria:

General Inclusion Criteria

• 18 to 80 years of age

• Presenting with symptoms consistent with an AIS

• Pre-stroke mRS score 0-1

• NIHSS score 6-30 at the time of randomization

• Ability to randomize within 24 hours of stroke onset

• Ability to obtain signed informed consent Specific Neuroimaging Inclusion Criteria

• Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment

• Imaging evidence of moderate-large infarct defined by either NCCT (ASPECTS: 3-5) advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: 70-100cc) (>6h/ <6h and ASPECT 0-2) or both.

Exclusion Criteria:

General Exclusion Criteria

• Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test;

• Known severe allergy (more than a rash) to contrast media uncontrolled by medications;

• Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg);

• Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >1.7 or Partial Thromboplastin Time (APTT) >35s; baseline platelet count <100X10^9/L;

• Biopsy of parenchymatous organs with 1 month

• Active bleeding within 1 month (such as gastrointestinal or urinary hemorrhage)

• Known severe renal failure (GFR <30ml/min or Scr>220mmol/L（2.5mg/dl）) or under the treatment of hematodialysis or peritoneal dialysis;

• Life expectancy less than 1 year prior to stroke onset (combined with malignant tumor, severe heart failure)

• All-cause acute intracranial hemorrhage or intracranial tumors with mass effect

• Participation in another randomized clinical trial that could confound the evaluation of the study

• Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed

Specific Neuroimaging Exclusion Criteria

• Midline shift, herniation or mass effect with effacement of the ventricles

• Evidence of acute intracranial hemorrhage

• Bilateral strokes or multiple intracranial vessels occlusions