Mechanical Thrombectomy (Penumbra System with Thunderbolt) for Cerebrovascular accident

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Piedmont Hospital Atlanta, Atlanta, GA
Cerebrovascular accident+7 More
Mechanical Thrombectomy (Penumbra System with Thunderbolt) - Device
Eligibility
18+
All Sexes
What conditions do you have?
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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. ThePenumbra System with Thunderbolt is a mechanical thrombectomy device that is used to treat cerebrovascular accidents. There is no placebo group in this clinical trial, as all patients will receive the device. The Penumbra System with Thunderbolt has previously been approved by the FDA for the treatment of a different condition.

Eligible Conditions

  • Cerebrovascular accident
  • Blood Vessel

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 24 Hrs Post-Procedure

24 Hrs Post-Procedure
Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)
90 Days Post-Procedure
Efficacy Endpoint: Modified Rankin Scale (mRS)
Safety Endpoint: All-cause mortality
Immediate Post Procedure
Efficacy Endpoint: Angiographic Revascularization
Index Procedure
Efficacy Endpoint: Angiographic Revascularization After First Pass
Efficacy Endpoint: Time to Revascularization
Up to 24hrs Post-Procedure
Safety Endpoint: Serious Adverse Events (SAEs)

Trial Safety

Trial Design

1 Treatment Group

Single Arm
1 of 1
Experimental Treatment

160 Total Participants · 1 Treatment Group

Primary Treatment: Mechanical Thrombectomy (Penumbra System with Thunderbolt) · No Placebo Group · N/A

Single Arm
Device
Experimental Group · 1 Intervention: Mechanical Thrombectomy (Penumbra System with Thunderbolt) · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hrs post-procedure
Closest Location: Piedmont Hospital Atlanta · Atlanta, GA
Photo of Atlanta 1Photo of Atlanta 2Photo of Atlanta 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Cerebrovascular accident
0 CompletedClinical Trials

Who is running the clinical trial?

Penumbra Inc.Lead Sponsor
32 Previous Clinical Trials
8,542 Total Patients Enrolled
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
Donald Frei, M.D.Principal InvestigatorHCA HealthONE, LLC (Swedish Medical Center)

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a pre-stroke mRS score of 0-2.
You have given informed consent for this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.