Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial (PICASSO)
Acute Ischemic Stroke
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Stroke, Ischemic Stroke, Thrombectomy
Eligibility Criteria
Inclusion Criteria: 18 to 85 years of age 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 within 24 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 MRI DWI (AxBxC/2) or CTP (rCBF<30%) for subjects >6h to -24 hours from stroke onset, given the need for antiplatelet therapy. Imaging obtained within 24 hours (after the first symptoms or last seen well. Arterial Access Obtained < 25 hours from stroke symptoms onset. Both study groups must adhere to identical blood pressure (BP) recommendations, which will be dependent on the cerebral perfusion status. Individuals with TICI2b or higher scores will be subject to BP recommendations ranging from 100-140 mmHg in cases of reperfusion and 120-180 mmHg in instances of no reperfusion and no evidence of intracranial hemorrhage (ICH) (TICI score < 2b). Acute Neurological Deficit with Imaging evidence of Tandem Lesion: Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion 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) despite medication CT evidence of the following conditions: Midline shift or herniation Evidence of intracranial hemorrhage Mass effect with effacement of the ventricles Acute bilateral strokes 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 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) Life expectancy less than one year prior to stroke onset Participation in another randomized clinical trial that could confound the evaluation of the study outcomes 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 Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis)
Sites / Locations
- Mercy Health St. Vincent Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
MT+CAT
MT+CAS
Non-stenting group constitutes best medical management (BMM)+intra-arterial treatment (IAT) with mechanical thrombectomy (for IVO) added to extra-cranial proximal carotid occlusion angioplasty or aspiration (MT+CAT)
Acute carotid stenting (ACS) approach constitutes BMM+IAT with acute carotid stenting (ACS) of the extracranial proximal carotid artery, spanning the cervical internal carotid artery (ICA), ICA origin, and the distal common carotid artery (CCA, across the bifurcation) as in the example of left (L) carotid stenting figure below (MT+CAS). Within the stenting arm, there will be 2 different subgroups based on the antiplatelet treatment protocol per the site standard of care (oral antiplatelet or IV antiplatelet medication (e.g., Cangrelor or others).