Acute Ischemic Stroke PatientsPlungerNCT07231380
A Comparison of Cyclic Manual Direct Aspiration Thrombectomy (Plunger Technique) vs. Static Manual Direct Aspiration Thrombectomy for Treatment of Acute Large Vessel Occlusion Stroke
A study testing Plunger Technique and Static Manual Aspiration Thrombectomy in people with Acute Ischemic Stroke Patients and Large Vessel Occlusion, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke Patients, Large Vessel Occlusion
- What is being tested?
- Plunger Technique and Static Manual Aspiration Thrombectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2026to 1 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Evidence of acute intracranial hemorrhage prior to treatment, Failure to obtain informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tejeswini Siva Sathya contact
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Anna Bican
Rohan Chitale
About this study
Official title: 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.
Read the 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.
- Being tested
- Plunger Technique, Static Manual Aspiration Thrombectomy
- Keywords
- Acute Ischemic Stroke, Large Vessel Occlusion, Mechanical Aspiration Thrombectomy, Plunger Technique, Stroke Intervention
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plunger TechniqueProcedure or surgery
Also called Cyclic Manual Aspiration Thrombectomy
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 ThrombectomyProcedure or surgery
Continuous suction without modulation using FDA-approved devices (Raptor Aspiration Catheter and VacLok Syringe) for clot removal in acute ischemic stroke.
| Study group | Role | What they receive |
|---|---|---|
| Plunger Technique arm | Active comparator | 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). Receives: Procedure: Plunger Technique |
| Manual Static Aspiration Arm | Active comparator | 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). Receives: Procedure: Static Manual Aspiration Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Pass Effect (FPE)
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.
Measured: During Procedure
Secondary outcomes (2)
Overall Recanalization Rate
Achievement of successful reperfusion (TICI 2b/3) by the end of the procedure.
Measured: During the procedure
90-Day Functional Outcome
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.
Measured: 90 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start4 Aug 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic Stroke PatientsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Balt USA
- Responsible party
- Principal investigator, Michael Froehler, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231380
- Sponsor's protocol ID
- 251059
- Acronym
- Plunger
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jablonska M, Li J, Tiberi R, Bayraktar EA, Bilgin C, Tomasello A, Ribo M. Cyclic Aspiration in Mechanical Thrombectomy: Influencing Factors and Experimental Validation. AJNR Am J Neuroradiol. 2024 Nov 7;45(11):1708-1715. doi: 10.3174/ajnr.A8369.
PubMed 38844372Poulos DA, Keith JS, Froehler MT, Good BC. Experimental evaluation of the plunger technique: A method of cyclic manual aspiration thrombectomy for treatment of acute ischemic stroke. Interv Neuroradiol. 2026 Aug;32(4):1225-1231. doi: 10.1177/15910199241230364. Epub 2024 Feb 6.
PubMed 38321875Marnat G, Barreau X, Detraz L, Bourcier R, Gory B, Sgreccia A, Gariel F, Berge J, Menegon P, Kyheng M, Labreuche J, Consoli A, Blanc R, Lapergue B; ETIS Investigators. First-Line Sofia Aspiration Thrombectomy Approach within the Endovascular Treatment of Ischemic Stroke Multicentric Registry: Efficacy, Safety, and Predictive Factors of Success. AJNR Am J Neuroradiol. 2019 Jun;40(6):1006-1012. doi: 10.3174/ajnr.A6074. Epub 2019 May 23.
PubMed 31122921Kang DH, Kim BM, Heo JH, Nam HS, Kim YD, Hwang YH, Kim YW, Kim DJ, Kim JW, Baek JH, Kim YS. Effects of first pass recanalization on outcomes of contact aspiration thrombectomy. J Neurointerv Surg. 2020 May;12(5):466-470. doi: 10.1136/neurintsurg-2019-015221. Epub 2019 Sep 28.
PubMed 31563889Gross BA, Jadhav AP, Jovin TG, Jankowitz BT. Dump the pump: manual aspiration thrombectomy (MAT) with a syringe is technically effective, expeditious, and cost-efficient. J Neurointerv Surg. 2018 Apr;10(4):354-357. doi: 10.1136/neurintsurg-2017-013520. Epub 2017 Nov 10.
PubMed 29127194Arslanian RA, Marosfoi M, Caroff J, King RM, Raskett C, Puri AS, Gounis MJ, Chueh JY. Complete clot ingestion with cyclical ADAPT increases first-pass recanalization and reduces distal embolization. J Neurointerv Surg. 2019 Sep;11(9):931-936. doi: 10.1136/neurintsurg-2018-014625. Epub 2019 Feb 4.
PubMed 30718384Froehler MT. Comparison of Vacuum Pressures and Forces Generated by Different Catheters and Pumps for Aspiration Thrombectomy in Acute Ischemic Stroke. Interv Neurol. 2017 Oct;6(3-4):199-206. doi: 10.1159/000475478. Epub 2017 May 18.
PubMed 29118797Lapergue B, Blanc R, Gory B, Labreuche J, Duhamel A, Marnat G, Saleme S, Costalat V, Bracard S, Desal H, Mazighi M, Consoli A, Piotin M; ASTER Trial Investigators. Effect of Endovascular Contact Aspiration vs Stent Retriever on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER Randomized Clinical Trial. JAMA. 2017 Aug 1;318(5):443-452. doi: 10.1001/jama.2017.9644.
PubMed 28763550Prabhakaran S, Ruff I, Bernstein RA. Acute stroke intervention: a systematic review. JAMA. 2015 Apr 14;313(14):1451-62. doi: 10.1001/jama.2015.3058.
PubMed 25871671Campbell BCV, Donnan GA, Lees KR, Hacke W, Khatri P, Hill MD, Goyal M, Mitchell PJ, Saver JL, Diener HC, Davis SM. Endovascular stent thrombectomy: the new standard of care for large vessel ischaemic stroke. Lancet Neurol. 2015 Aug;14(8):846-854. doi: 10.1016/S1474-4422(15)00140-4. Epub 2015 Jun 25.
PubMed 26119323