What side effects are associated with this type of intervention?

Mechanical thrombectomy, a common treatment for acute ischemic stroke due to large vessel occlusion, can have several side effects. These include bleeding or hemorrhage at the puncture site or within the brain, vessel damage, infection, and reactions to contrast dye used during the procedure. Other potential complications are stroke recurrence, arterial dissection, and, in rare cases, death. Despite these risks, mechanical thrombectomy is often considered when the benefits outweigh the potential side effects.

What prior FDA approvals exist?

The FDA has approved several devices for the treatment of acute ischemic stroke, particularly those involving mechanical thrombectomy to remove blood clots in cases of intracranial large vessel occlusion. Notable among these are the Solitaire™ FR Revascularization Device and the Trevo® ProVue Retriever, both of which are designed to restore blood flow by mechanically removing the clot. These devices have shown efficacy in improving outcomes for patients experiencing severe strokes by quickly re-establishing cerebral circulation.

What other types of research exist?

Promising novel alternatives to the Penumbra System for mechanical thrombectomy in stroke patients include the following: 1) Stent retrievers, such as the Solitaire and Trevo devices, which have shown high efficacy in clot retrieval. 2) Direct aspiration first pass technique (ADAPT) using devices like the AXS Catalyst. 3) Newer aspiration catheters with improved design for better navigation and clot removal, such as the Zoom Aspiration Catheter. 4) Combination approaches that utilize both stent retrievers and aspiration devices to maximize clot removal efficiency. These alternatives are being refined and tested to improve outcomes for stroke patients.

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Mechanical Thrombectomy Device

Mechanical Thrombectomy for Stroke

N/A

Waitlist Available

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

Must not have

Alberta Stroke Program Early CT Score (ASPECTS) ≤6 or core infarct volume >50 mL on MRI or CT-based imaging (for anterior circulation strokes)

Stenosis, excessive tortuosity, or any occlusion in a proximal vessel requiring treatment or preventing access to the thrombus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up index procedure

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My stroke has severely affected my brain, as shown by MRI or CT scans.

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I have a blocked or very twisted blood vessel that needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Efficacy Endpoint: Angiographic Revascularization

Efficacy Endpoint: Angiographic Revascularization After First Pass

Efficacy Endpoint: Modified Rankin Scale (mRS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met

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.