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)

May 15, 2026 updated by: Michael Froehler, Vanderbilt University Medical Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Tejeswini Siva Sathya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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.
Other Names:
  • Cyclic Manual Aspiration Thrombectomy
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Recanalization Rate
Time Frame: During the procedure
Achievement of successful reperfusion (TICI 2b/3) by the end of the procedure.
During the procedure
90-Day Functional Outcome
Time Frame: 90 days post procedure
Modified Rankin Scale (mRS) score at 90 days post-procedure.Modified Rankin Scale (mRS), ranges from 0 (no symptoms) to 6 (death); higher scores indicate worse functional outcome.
90 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

Balt USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 251059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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