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NCT01429350 · ClinicalTrials.gov registry record · Phase 4
Assess the Penumbra System in the Treatment of Acute Stroke
A Phase 4 study of Ischemic Stroke, sponsored by Penumbra.
- Completed
- Registry status
- Phase 4
- Development phase
- 108
- Enrollment target
- 4
- Study locations
NCT01429350: Completed Phase 4 study of Ischemic Stroke, sponsored by Penumbra.
NCT01429350 is a Phase 4 study of Ischemic Stroke that has completed, run by Penumbra. The registered enrollment target is 108 participants, below the 1,462-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (93% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01429350, a Phase 4 study of Ischemic Stroke, has completed, sponsored by Penumbra.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 108 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV rtPA is the only drug approved for the treatment of acute ischemic stroke but it does not work very well in cases where the stroke is caused by a large vessel occlusion. The hypothesis being tested is to determine if the addition of a treatment by a mechanical thrombectomy device like the Penumbra System can improve the clinical outcome of the patient over just using IV rtPA alone.
Primary Outcome
The assessor is blinded to patient treatment assignment.
Conditions Studied
Interventions
- DRUG intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
- DEVICE Penumbra System
Study Locations (4)
Colorado
- Endovascular Surgical Neuroradiology, Swedish Medical Center - Denver
Florida
- Department of Neurological Surgery - Gainesville
Illinois
- Neurosurgery, Rush University Medical Center - Chicago
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 4 |
What the finished NCT01429350 record still lists
NCT01429350 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 1,462-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Ischemic Stroke appearing as the primary indexed condition, and to 2 interventions - of which intravenous (IV) recombinant human tissue plasminogen activator (rtPA) is the first listed.
NCT01429350 reports a single indexed study location in Colorado, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT01429350 about?
NCT01429350 is a clinical study titled "Assess the Penumbra System in the Treatment of Acute Stroke". The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV rtPA is the only drug app...
What is the current status of trial NCT01429350?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2012-05. Estimated completion is 2016-10.
What conditions does trial NCT01429350 study?
This clinical trial studies the following conditions: Ischemic Stroke.
What interventions are being tested in trial NCT01429350?
The interventions under investigation include: intravenous (IV) recombinant human tissue plasminogen activator (rtPA) (DRUG), Penumbra System (DEVICE).
Who is sponsoring clinical trial NCT01429350?
This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01429350 being conducted?
This trial has 4 study locations across Colorado, Florida, Illinois, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT01429350's enrollment target sits among peer trials
108 31st of 66 higher than 36 of 66 other Ischemic Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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