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Plunger Stroke 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 With the Raptor Aspiration Catheter

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \- 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

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Michael T Froehler
m.froehler@vumc.org
6154210300
Backup
Tejeswini Siva Sathya
Time Frame
Start Date: 2026-08-10
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 500
Treatments
Active_comparator: Plunger Technique arm
Participants randomized to this arm will undergo cyclic manual aspiration thrombectomy, also known as the Plunger Technique. This technique involves rhythmic, cyclic application of suction using FDA-approved devices: the Raptor Aspiration Catheter and VacLok Syringe, to remove thrombus in cases of acute ischemic stroke due to large vessel occlusion (terminal ICA or M1 segment of MCA).
Active_comparator: Manual Static Aspiration Arm
Participants randomized to this arm will undergo static manual aspiration thrombectomy, which involves continuous suction without modulation. The procedure will use FDA-approved devices: the Raptor Aspiration Catheter and VacLok Syringe, to remove thrombus in cases of acute ischemic stroke due to large vessel occlusion (terminal ICA or M1 segment of MCA).
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center
Collaborators: Balt USA

This content was sourced from clinicaltrials.gov