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

Vanderbilt University Medical Center

Status: Begins enrollment this month

Conditions: Large Vessel Occlusion; Acute Ischemic Stroke Patients

Treatments: Procedure: Plunger Technique; Procedure: Static Manual Aspiration Thrombectomy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07231380

251059

Details and patient eligibility

About

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.

Full description

This is a prospective, randomized, controlled, multi-center trial designed to compare two manual aspiration thrombectomy techniques for the treatment of acute ischemic stroke due to large vessel occlusion (LVO):

Cyclic Manual Aspiration (Plunger Technique): A rhythmic, cyclic application of suction, coined by Principal Investigator Dr. Michael Froehler.

Static Manual Aspiration: Continuous suction without modulation.

Both techniques will utilize FDA-approved devices, the Raptor Aspiration Catheter and VacLok Syringe which are routinely employed in clinical practice for stroke treatment. While both approaches are widely accepted, there is currently limited comparative data evaluating their relative efficacy and safety.

The study will enroll approximately 500 participants across 20 sites. Eligible patients will present with acute ischemic stroke involving the terminal internal carotid artery (ICA) or M1 segment of the middle cerebral artery (MCA). Participants will be randomized centrally in a 1:1 ratio to one of the two aspiration techniques.

Primary Endpoint:

First Pass Effect (FPE): Defined as achieving a Thrombolysis in Cerebral Infarction (TICI) score of 2c or 3 following the first attempt at clot removal.

Secondary Endpoints:

Overall recanalization rates 90-day functional outcomes (modified Rankin Scale) Successful catheter navigation to the occlusion site Procedural efficiency metrics

Both techniques are considered standard of care at Vanderbilt University Medical Center (VUMC) and other participating institutions. The study does not introduce any novel devices or untested procedures; therefore, risks to participants are minimal and comparable to routine thrombectomy procedures.

This trial addresses a critical gap in current knowledge regarding optimal manual aspiration techniques for direct aspiration thrombectomy in acute ischemic stroke. Results will provide high-quality evidence to inform best practices, potentially improving procedural efficiency and patient outcomes.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Plunger Technique arm

Active Comparator group

Description:

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).

Treatment:

Procedure: Plunger Technique

Manual Static Aspiration Arm

Active Comparator group

Description:

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).

Treatment:

Procedure: Static Manual Aspiration Thrombectomy