This prospective, randomized controlled trial will compare two manual aspiration techniques for treating acute ischemic stroke due to large vessel occlusion: cyclic aspiration (Plunger technique) and static aspiration. Both techniques use FDA-approved devices (Raptor Aspiration Catheters and VacLok syringes) and are standard of care. Approximately 500 participants across 20 sites will be randomized to one of the two techniques. The primary endpoint is First Pass Effect (TICI 2c/3 after first attempt), with secondary endpoints including overall recanalization and 90-day functional outcomes. Results will address a critical gap in optimizing aspiration thrombectomy techniques.
None
Evidence of acute intracranial hemorrhage prior to treatment, Failure to obtain informed consent
Parallel
Plunger Technique
Procedure/SurgeryRhythmic, cyclic application of suction using FDA-approved devices (Raptor Aspiration Catheter and VacLok Syringe) for clot removal in acute ischemic stroke.
Static Manual Aspiration Thrombectomy
Procedure/SurgeryContinuous suction without modulation using FDA-approved devices (Raptor Aspiration Catheter and VacLok Syringe) for clot removal in acute ischemic stroke.
First Pass Effect (FPE)
Achieving a Thrombolysis in Cerebral Infarction (TICI) score of 2c or 3 following the first attempt at clot removal.First Pass Effect (FPE): Thrombolysis in Cerebral Infarction (TICI) scale, ranges from 0 (no perfusion) to 3 (complete perfusion); higher scores indicate better reperfusion.
Overall Recanalization Rate
Achievement of successful reperfusion (TICI 2b/3) by the end of the procedure.
90-Day Functional Outcome
Modified Rankin Scale (mRS) score at 90 days post-procedure.Modified Rankin Scale (mRS), ranges from 0 (no symptoms) to 6 (death); higher scores indicate worse functional outcome.
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Vanderbilt University Medical Center
Lead sponsor
Balt USA
Collaborator
