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Mechanical Thrombectomy Device

Mechanical Thrombectomy for Stroke

N/A
Recruiting
Led By Donald Frei, M.D.
Research Sponsored by Penumbra Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre-stroke mRS 0-2
Patient age 18 - 80 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post-procedure
Awards & highlights

Study Summary

This trial is testing a new system for emergency treatment of strokes caused by a blockage in a large brain vessel. The system includes a device that suctions out the blockage. The study will compare how well this new system works compared to the standard of care.

Who is the study for?
This trial is for adults aged 18-80 with acute ischemic stroke due to a blockage in major brain arteries, who can receive treatment within 8 hours of symptom onset. They should have been relatively healthy before the stroke (mRS score 0-2). Pregnant individuals, those with life expectancy under 90 days, or current participation in other drug/device trials are excluded.Check my eligibility
What is being tested?
The THUNDER study tests the safety and effectiveness of the Penumbra System with Thunderbolt Aspiration Tubing for removing clots from large brain vessels in patients experiencing an acute ischemic stroke.See study design
What are the potential side effects?
While specific side effects aren't listed here, mechanical thrombectomy procedures like this one may cause risks such as bleeding at the catheter insertion site, damage to blood vessels, possible allergic reactions to contrast dye used during the procedure, and risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was independent in daily activities before my stroke.
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I am between 18 and 80 years old.
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I had a stroke due to a blockage in a major brain artery.
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I received clot-dissolving medication within 3 hours of my stroke symptoms starting.
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I am scheduled for treatment with the Penumbra System.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24hrs post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24hrs post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)
Secondary outcome measures
Efficacy Endpoint: Angiographic Revascularization
Efficacy Endpoint: Angiographic Revascularization After First Pass
Efficacy Endpoint: Modified Rankin Scale (mRS)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Stroke treatments aim to restore blood flow to the brain and minimize damage. Mechanical thrombectomy, such as the Penumbra System with Thunderbolt Aspiration Tubing, involves the physical removal of a blood clot from a large vessel in the brain. This is achieved by inserting a catheter through the blood vessels to the site of the clot and using suction or other mechanical means to extract it. This treatment is crucial for stroke patients because it can rapidly restore blood flow, reduce brain damage, and improve outcomes, especially when performed within a critical time window after stroke onset.

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Who is running the clinical trial?

Penumbra Inc.Lead Sponsor
36 Previous Clinical Trials
9,335 Total Patients Enrolled
13 Trials studying Stroke
3,182 Patients Enrolled for Stroke
Donald Frei, M.D.Principal InvestigatorHCA HealthONE, LLC (Swedish Medical Center)
David Fiorella, M.D.Principal InvestigatorThe Research Foundation for The State University of New York (Stony Brook University)
1 Previous Clinical Trials
153 Total Patients Enrolled
~73 spots leftby Mar 2025