Independent Investigator-initiated, designed and conducted non-industry study. A prospective, phase III, randomized, open-label, blinded-endpoint controlled trial (PROBE Design).
Patients presenting with symptoms of AIS in the anterior circulation with proximal carotid occlusive disease will be assigned to either best medical management (BMM)+/-intra-arterial treatment (IAT) with mechanical thrombectomy (for IVO) added to proximal extra-cranial carotid occlusion none stenting thrombectomy treatment (CAT) none stenting: angioplasty, aspiration or atherectomy) (BMM+/-IAT+CAT without stenting) approach VERSUS BMM+/-IAT with added carotid thrombectomy using stenting (BMM+/-IAT+CAT with Stenting) approach.
Randomization will be 1:1, with stratification by: 1) age, 2) National Institute of Health Stroke Scale (NIHSS), 3) degree of proximal extra-cranial carotid stenosis (complete occlusion versus stenosis), 4) IV lytic administration, 5) time from onset to randomization CTA imaging confirming ICA occlusion/tandem lesion, 6) and ASPECT score.
Within the stenting arm, there will be 3 different subgroups based on the antiplatelet treatment protocol per the site standard of care (Single antiplatelet, dual oral antiplatelet or IV antiplatelet medication (e.g.Cangrelor or others). Each arm will be assessed at the first interim analysis to consider dropping an arm; if predetermined safety boundaries are exceeded.
Mechanical thrombectomy and proximal angioplasty or stenting will be performed with an FDA-cleared devices in accordance with the instructions for use (IFU). The order of each procedure (revascularization of the proximal extra-cranial carotid lesion first or after the intracranial lesion) will be left at discretion of the treating proceduralist.
Each treated patient will be followed and assessed for the primary outcome at 3 months and one year after randomization by an independent adjudicator not involved in the procedure. Optional utilization of remote assessment of NIHSS, mRS scale may be provided to selected site (NeuroMerit Clinical Core Lab).
Source: View full study details on ClinicalTrials.gov
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