Recruiting

Cyclic Aspiration & Static Aspiration

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07231380

Conditions

Acute Ischemic Stroke Patients

Large Vessel Occlusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Plunger Technique

Static Manual Aspiration Thrombectomy

Study Details

Brief 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.

Conditions

Acute Ischemic Stroke Patients

Large Vessel Occlusion

Study ID

NCT07231380

Start date

Aug 10, 2026

Status verified date

Aug, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Plunger Technique

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

Continuous suction without modulation using FDA-approved devices (Raptor Aspiration Catheter and VacLok Syringe) for clot removal in acute ischemic stroke.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Michael T Froehler

6154210300m.froehler@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Michael Froehler

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Acute Ischemic Stroke
  • Large Vessel Occlusion
  • Mechanical Aspiration Thrombectomy
  • Plunger Technique
  • Stroke Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-08-24.