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

Conditions

• Acute Ischemic Stroke Patients
• Large Vessel Occlusion

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Plunger Technique — PROCEDURE
  Rhythmic, 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
  Continuous suction without modulation using FDA-approved devices (Raptor Aspiration Catheter and VacLok Syringe) for clot removal in acute ischemic stroke.

Study Details

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.

Key Dates

First listed

Nov 17, 2025

Start date

Aug 10, 2026

Status verified

Aug 2026

Primary completion

Jun 1, 2027

Completion

Jun 1, 2027

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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).

Primary Outcome Measure

First Pass Effect (FPE) [ Time Frame: During Procedure ]

Central Contacts

• Michael T Froehler
  6154210300
  [email protected]
• Tejeswini Siva Sathya

Locations (1)

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