Clinical Trial

A Comparison of Cyclic Manual Direct Aspiration Thrombectomy (Plunger Technique) vs. Static Manual Direct Aspiration Thrombectomy for Treatment of Acute Large Vessel Occlusion Stroke

Study acronym: Plunger
Not Yet Recruiting
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Summary
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-12-01 -> 2027-06-01 2026-05-20
minor Completion pushed: 2027-03-01 -> 2027-06-01 2026-05-20
Trial Details
NCT Number NCT07231380
Lead Sponsor Vanderbilt University Medical Center
Collaborators: Balt USA
Conditions Acute Ischemic Stroke Patients, Large Vessel Occlusion
Enrollment 500 participants
Start Date 2026-07-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-19