Mechanical Thrombectomy for Stroke

Recruiting in Palo Alto (17 mi)

+31 other locations

Overseen byDavid Fiorella, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Penumbra Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a device called the Penumbra System with Thunderbolt, which removes blood clots from the brain. It targets patients who have had a stroke due to a large vessel blockage and are eligible for clot removal procedures. The device works like a vacuum to clear the blockage and restore blood flow. The Penumbra System has been previously reported to be effective and safe in treating acute stroke caused by large intracranial vessel occlusion.

Research Team

Donald Frei, M.D.

Principal Investigator

HCA HealthONE, LLC (Swedish Medical Center)

David Fiorella, M.D.

Principal Investigator

The Research Foundation for The State University of New York (Stony Brook University)

Eligibility Criteria

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.

Inclusion Criteria

I was independent in daily activities before my stroke.

I received clot-dissolving medication within 3 hours of my stroke symptoms starting.

I am between 18 and 80 years old.

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Exclusion Criteria

You are not expected to live more than three months due to other health problems.

Other medical, behavioral, or psychological conditions that in the opinion of the Investigator could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Pregnant patient

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Treatment Details

Interventions

Penumbra System with Thunderbolt (Mechanical Thrombectomy Device)

Trial OverviewThe 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.

Participant Groups

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