A Comparison of Cyclic Manual Direct Aspiration Thrombectomy (Plunger Technique) vs. Static Manual Direct Aspiration Thrombectomy for Treatment of Acute Large Vessel Occlusion Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Plunger Technique, Static Manual Aspiration Thrombectomy.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke Patients, Large Vessel Occlusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Interventions
- 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. - 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.
Primary outcome measures
- First Pass Effect (FPE) [Time frame: During Procedure]
Secondary outcome measures (2)
- Overall Recanalization Rate [Time frame: During the procedure]
- 90-Day Functional Outcome [Time frame: 90 days post procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 38844372
- Poulos 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. 2024 Feb 6:15910199241230364. doi: 10.1177/15910199241230364. Online ahead of print. PMID 38321875
- Marnat 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: PMID 31122921
- Kang 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. PMID 31563889
- Gross 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. PMID 29127194
- Arslanian 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. PMID 30718384
- Froehler 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. PMID 29118797
- Lapergue 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 PMID 28763550
Identifiers
NCT: NCT07231380 · 251059