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NCT01584609 · ClinicalTrials.gov registry record · NA
A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
A NA study, sponsored by Penumbra.
- Completed
- Registry status
- NA
- Development phase
- 198
- Enrollment target
NCT01584609 is a NA study that has completed, run by Penumbra. The registered enrollment target is 198 participants.
The verdict
NCT01584609, a NA study, has completed, sponsored by Penumbra.
- COMPLETED
- Registry status
- NA
- Development phase
- 198 participants
- Enrollment target
Study Summary
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D. Each treated patient will be followed and assessed for 3 months after randomization. Up to 230 evaluable patients at up to 50 centers presenting with acute ischemic stroke in vessels accessible to the Penumbra Separator 3D System for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Penumbra System with the Separator 3D for the revascularization of large vessel occlusion is not inferior to the Penumbra System alone.
Interventions
- DEVICE Penumbra System with Separator 3D
- DEVICE Penumbra System alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2012-04 |
| Est. Completion | 2017-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01584609
The ClinicalTrials.gov registry entry for NCT01584609 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 198 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penumbra, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Penumbra System with Separator 3D is the first listed.
NCT01584609 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01584609 about?
NCT01584609 is a clinical study titled "A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke". This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra Syst...
What is the current status of trial NCT01584609?
This trial is currently completed. It is a NA study. The enrollment target is 198 participants. The study started on 2012-04. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01584609?
The interventions under investigation include: Penumbra System with Separator 3D (DEVICE), Penumbra System alone (DEVICE).
Who is sponsoring clinical trial NCT01584609?
This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.
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