Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

Korábbi kezelés

• Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents.
• Intracranial tumors other than small meningioma that does not require surgery for one year post randomization
• Life expectancy less than one year prior to stroke onset

Más betegség

• 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) despite medication
• CT evidence of the following conditions:
  • Midline shift or herniation
  • Evidence of intracranial hemorrhage
  • Mass effect with effacement of the ventricles
• 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

Laborértékek

• Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
• Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >1.7 or Partial Thromboplastin Time (PTT) > 3 times of normal
• Baseline platelet count <100,000 per microliter (μl)

Egyéb

• Acute bilateral strokes
• Participation in another randomized clinical trial that could confound the evaluation of the study outcomes
• Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis)

• 18 to 79 years of age (before the 80th birthday)
• Presenting with symptoms consistent with AIS
• Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND extra-cranial proximal carotid occlusion / severe stenosis related to atherosclerosis requiring treatment on non-invasive imaging ≥70%
• NIHSS ≥ 4
• Ability to randomize and start endovascular therapy within 16 hours of stroke onset
• Pre-stroke mRS score 0-2
• Ability to obtain signed informed consent
• ASPECTS Score ≥7 via non-contrast CT or MRI (DWI) for subjects ≤6 hours from stroke onset OR ASPECTS Score ≥7 + infarct core volume <50 cc quantified by CTP (rCBF<30%) OR <25 cc quantified by MRI-DWI (AxBxC/2) for subjects with endovascular therapy starting between >6h to 16 hours from stroke onset, given the need for antiplatelet therapy.
• Acute Neurological Deficit with Imaging evidence of Tandem Lesion:
  • Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion
• Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy