500 Participants NeededMy employer runs this trial

Aspiration Thrombectomy for Stroke

(Plunger Trial)

MT
TS
Overseen ByTejeswini Siva Sathya
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two techniques for removing blood clots in individuals who have experienced a stroke due to a blocked large blood vessel. The Cyclic Manual Direct Aspiration Thrombectomy (Plunger Technique) employs rhythmic suction, while the Static Manual Direct Aspiration Thrombectomy uses continuous suction to clear the blockage. Both methods utilize approved devices that doctors currently use for these treatments. Suitable candidates have had a stroke caused by a blocked artery in the brain and can begin treatment within 24 hours of their initial symptoms. The trial aims to determine which method more effectively reopens the blocked blood vessel and improves outcomes. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance stroke treatment techniques.

What prior data suggests that these aspiration techniques are safe for treating acute ischemic stroke?

Research has shown that both cyclic and static manual aspiration techniques are generally safe for treating sudden strokes caused by blocked blood vessels. These methods use FDA-approved devices commonly employed in stroke treatments.

Studies on direct aspiration thrombectomy have demonstrated that it effectively removes clots from large blood vessels and significantly improves stroke recovery. This procedure is considered safe when performed with devices used in this trial, such as the Raptor Aspiration Catheter and VacLok Syringe.

Previous patients have generally tolerated these aspiration procedures well. Major reports of problems specifically linked to the aspiration techniques themselves have not been noted. However, like any medical procedure, there is always a risk of complications. These techniques aim to minimize such risks and ensure safety.

Overall, evidence suggests that both the Plunger Technique and the static aspiration method are safe options for stroke treatment.12345

Why are researchers excited about this trial?

Researchers are excited about the aspiration thrombectomy techniques being tested because they offer a new approach to removing blood clots in stroke patients. Unlike traditional methods, which often involve mechanical clot retrieval devices, these techniques use suction to directly remove the clot. The Plunger Technique stands out with its rhythmic, cyclic application of suction, potentially increasing efficiency in clot removal. Meanwhile, the Static Aspiration method provides continuous suction, simplifying the procedure. These methods could improve outcomes in patients with acute ischemic stroke by offering a more direct and possibly safer way to clear blocked blood vessels.

What evidence suggests that this trial's techniques could be effective for stroke?

This trial compares two methods for removing clots in stroke patients: the Plunger Technique and static manual aspiration. Research has shown that the Plunger Technique, used by participants in one arm of this trial, may outperform other methods. This technique employs rhythmic suction to capture and remove clots more effectively. Conversely, participants in another arm will undergo static manual aspiration, which uses continuous suction and also effectively removes clots. Both techniques use FDA-approved devices and are standard treatments for strokes caused by large vessel blockages.678910

Are You a Good Fit for This Trial?

This trial is for adults (18+) who have had an acute ischemic stroke caused by a blockage in major brain arteries (terminal ICA or M1 segment of MCA) and can start treatment within 24 hours of symptoms.

Inclusion Criteria

I am 18 or older and had a major stroke within the last 24 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo either cyclic manual aspiration thrombectomy (Plunger Technique) or static manual aspiration thrombectomy using FDA-approved devices

During procedure
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, with functional outcomes assessed at 90 days post-procedure

90 days
1 visit (in-person) at 90 days

What Are the Treatments Tested in This Trial?

Interventions

  • Cyclic Manual Direct Aspiration Thrombectomy (Plunger Technique)
  • Static Manual Direct Aspiration Thrombectomy

Trial Overview

The study compares two ways to remove blood clots from blocked brain vessels: the Plunger technique (cyclic aspiration) versus static manual aspiration. Participants are randomly assigned to one method, both using standard FDA-approved devices.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Plunger Technique armActive Control1 Intervention
Group II: Manual Static Aspiration ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Balt USA

Industry Sponsor

Trials
2
Recruited
910+

Citations

A method of cyclic manual aspiration thrombectomy for ... - PMC

The results of this study indicate that manual cyclic aspiration via the plunger technique can potentially increase the success rate of direct aspiration ...

A Comparison of Cyclic Manual Direct Aspiration ...

This prospective, randomized controlled trial will compare two manual aspiration techniques for treating acute ischemic stroke due to large ...

251059 Plunger Stroke Trial IRB Approval date 11/04/2025

A sample size of 500 subjects will detect a 15% absolute difference in successful first pass rate between the two groups at 90% power.

A Comparison of Cyclic Manual Direct Aspiration ...

This prospective, randomized controlled trial will compare two manual aspiration techniques for treating acute ischemic stroke due to large ...

The fluid mechanics of aspiration thrombectomy

The benefits of cyclic aspiration have been demonstrated in previous experimental studies,24–27 where it has outperformed static aspiration techniques

Efficacy of beveled tip aspiration catheter in mechanical ...

Objectives: Mechanical thrombectomy for acute ischemic stroke needs to be performed in the shortest possible workflow time and have a high recanalization rate.

8 Direct Aspiration Thrombectomy for Acute Stroke

Thrombectomy techniques for achieving recanalization of an occluded large vessel occlusion have undergone rapid advances since the first approved device.

Mechanical Thrombectomy of Acute Ischemic Stroke ...

Endovascular thrombectomy is well established as a highly effective treatment for acute ischemic stroke (AIS) due to proximal, large vessel ...

The Aspirations of Direct Aspiration for Thrombectomy in ...

This review is a critical analysis of the evidence supporting the principle of direct aspiration functional outcomes in the various thrombectomy trials.

Exploring the efficacy of cyclic vs static aspiration in a ...

Cyclic aspiration outperformed static aspiration in overall clot removal and removal speed (p<0.001). Within cyclic aspiration, Max Hz frequencies (∼6.3 Hz) ...