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

NCT07231380 | Not Yet Recruiting DMC

• 1 other identifier: 251059
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  During Procedure

Secondary Outcomes (2)

• Overall Recanalization Rate

  During the procedure

• 90-Day Functional Outcome

  90 days post procedure

Study Arms (2)

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).

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).

Procedure: Static Manual Aspiration Thrombectomy

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.

Also known as: Cyclic Manual Aspiration Thrombectomy

Plunger Technique arm

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.

Manual Static Aspiration Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• Evidence of acute intracranial hemorrhage prior to treatment, Failure to obtain informed consent

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Balt USA: collaborator

Related Publications (10)

• 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 RESULT

• 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 RESULT

• 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: 10.3174/ajnr.A6074. Epub 2019 May 23.

  PMID: 31122921 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.2017.9644.

  PMID: 28763550 RESULT

• Prabhakaran 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.

  PMID: 25871671 RESULT

• Campbell 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.

  PMID: 26119323 RESULT

Related Links

• Plunger technique

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Michael T Froehler

CONTACT

6154210300; m.froehler@vumc.org

Tejeswini Siva Sathya

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share