The primary objective is to establish the efficacy of intra-arterial (IA) mechanical thrombectomy (MT) with extracranial proximal carotid artery acute stenting versus non-stenting approaches in patients with acute ischemic stroke (AIS) from intracranial vessel occlusion (IVO) in the anterior circulation and have a proximal carotid occlusive disease (occlusion or severe stenosis).
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
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
Midline shift or herniation
Parallel
MT+CAS with IV-AP
Procedure/SurgeryMechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added intravenous antiplatelet therapy.
MT+CAS with PO-AP
Procedure/SurgeryMechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy.
MT+CAT with PO-AP
Procedure/SurgeryMechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy
90-day Modified Rankin Scale ordinal shift
Scale used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death. 0 = No symptoms at all. 1. No significant disability despite symptoms; able to carry out all usual duties and activities. 2. Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3. Moderate disability requiring some help, but able to walk without assistance. 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5. Severe disability; bedridden, incontinent, and requiring constant nursing care and attention. 6. Death
Click on the lead sponsor to view all of their trials.
