NCT07231380 · Vanderbilt University Medical Center
A Comparison of Cyclic Manual Direct Aspiration Thrombectomy (Plunger Technique) vs. Static Manual Direct Aspiration Thrombectomy for Treatment of Acute Large Vessel Occlusion Stroke
(Plunger)
What this study is about
This forward-looking, randomly assigned 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 the usual treatment.
View original scientific description
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.
Interventions
PROCEDURE
Plunger Technique
Rhythmic, cyclic application of suction using FDA-approved devices (Raptor Aspiration Catheter and VacLok Syringe) for clot removal in acute ischemic stroke.
PROCEDURE
Static Manual Aspiration Thrombectomy
Continuous suction without modulation using FDA-approved devices (Raptor Aspiration Catheter and VacLok Syringe) for clot removal in acute ischemic stroke.
Primary outcome measures
First Pass Effect (FPE)
Time frame: During Procedure
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \- Acute ischemic stroke due to occlusion of the terminal ICA or M1 segment of the MCA, Treatment can be initiated within 24 hours of symptom onset, Age 18 years or older
Exclusion criteria
- Evidence of acute intracranial hemorrhage prior to treatment, Failure to obtain informed consent
Where
- Nashville, Tennessee
Collaborators
Balt USA
Related conditions & keywords
Frequently asked questions
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced Aug 24, 2026 · Source of record for eligibility and locations