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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

Find a Location

Who is running the clinical trial?

Penumbra Inc.Lead Sponsor
35 Previous Clinical Trials
8,835 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for this trial below 60 years old?

"To be part of this study, individuals must fit within the age bracket of 18 to 80. For those below or above that range, 73 and 1257 trials are available respectively."

Answered by AI

Is it feasible for me to partake in this medical experiment?

"In order to qualify, potential candidates must have suffered a stroke and be between 18-80 years of age. As of now, around 160 individuals are eligible for selection in this trial."

Answered by AI

To what extent is this trial being administered in medical facilities?

"Patients are welcome to enroll in this clinical trial at UMass Memorial Medical Center, which is located in Worcester Massachusetts, Abbott Northwestern (Minneapolis Minnesota) and Christus Trinity Medical Centre in Tyler Texas. There are 8 other sites open for enrollment as well."

Answered by AI

What is the total sample size of participants in this clinical trial?

"Affirmative. Patients are still being accepted for this medical trial, with the details first posted on August 11th 2022 and last updated November 2nd 2022. The research requires 160 participants from a total of eleven sites."

Answered by AI

Are there still available slots for participants in this research?

"Affirmative. The information documented on clinicaltrials.gov demonstrates that this trial is actively seeking participants, with the listing having been first posted on August 11th 2022 and most recently modified on November 2nd 2022. 160 individuals are anticipated to participate at 11 distinct research sites."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Stonybrook U.
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing
2022. "THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05437055.
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