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NCT05437055 · ClinicalTrials.gov registry record · NA
THUNDER: Acute Ischemic Stroke Study with the Penumbra System® Including Thunderbolt™ Aspiration Tubing
A NA study of Acute Ischemic Stroke and Large Vessel Occlusion, sponsored by Penumbra.
- Completed
- Registry status
- NA
- Development phase
- 216
- Enrollment target
- 20
- Study locations
NCT05437055: Completed NA study of Acute Ischemic Stroke and Large Vessel Occlusion, sponsored by Penumbra.
NCT05437055 is a NA study of Acute Ischemic Stroke and Large Vessel Occlusion that has completed, run by Penumbra. The registered enrollment target is 216 participants, below the 343-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05437055, a NA study of Acute Ischemic Stroke and Large Vessel Occlusion, has completed, sponsored by Penumbra.
- COMPLETED
- Registry status
- NA
- Development phase
- 216 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to demonstrate the safety and efficacy of the Penumbra System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy.
Primary Outcome
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by mTICI 2b or higher. \*mTICI ranges from 0-3, with higher grading representing better outcome
Conditions Studied
Interventions
- DEVICE Mechanical Thrombectomy (Penumbra System with Thunderbolt)
Study Locations (20)
Florida
- Jackson Memorial (U. of Miami) - Miami
- St. Joseph - BayCare - Tampa
Georgia
- Piedmont Hospital Atlanta - Atlanta
- Wellstar Kennestone Hospital - Marietta
Illinois
- North Shore U. - Evanston
- Edward Elmhurst Health - Naperville
Massachusetts
- Massachusetts General - Boston
- UMass Memorial Medical Center - Worcester
New York
- Albany Medical Center - Albany
- University of Buffalo - Buffalo
Arizona
- Abrazo West Campus - Goodyear
California
- Sharp Grossmont - San Diego
Colorado
- HRI - Swedish - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2022-08-11 |
| Est. Completion | 2024-12-10 |
| Phase | NA |
What the finished NCT05437055 record still lists
NCT05437055 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 343-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (37% lower).
The record links to 2 conditions, with Acute Ischemic Stroke appearing as the primary indexed condition, and to 1 intervention - of which Mechanical Thrombectomy (Penumbra System with Thunderbolt) is the first listed.
NCT05437055 names 20 study sites across 15 states, led by Florida, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT05437055 about?
NCT05437055 is a clinical study titled "THUNDER: Acute Ischemic Stroke Study with the Penumbra System® Including Thunderbolt™ Aspiration Tubing". The objective of this study is to demonstrate the safety and efficacy of the Penumbra System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thromb...
What is the current status of trial NCT05437055?
This trial is currently completed. It is a NA study. The enrollment target is 216 participants. The study started on 2022-08-11. Estimated completion is 2024-12-10.
What conditions does trial NCT05437055 study?
This clinical trial studies the following conditions: Acute Ischemic Stroke, Large Vessel Occlusion.
What interventions are being tested in trial NCT05437055?
The interventions under investigation include: Mechanical Thrombectomy (Penumbra System with Thunderbolt) (DEVICE).
Who is sponsoring clinical trial NCT05437055?
This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05437055 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Ischemic Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05437055's enrollment target sits among peer trials
216 12th of 25 higher than 14 of 25 other Acute Ischemic Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Ischemic Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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