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
Recruiting
Phase 2/3 Results N/ASummary of Purpose
This is a prospective, randomized, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (>3mm 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...
Read More →Trial Milestones
The following dates are available for this trial. Trial information last updated on 1 February 2013.
| 1 Apr 2012 | 23 Apr 2012 | 1 Jul 2013 | 1 Sep 2013 | 1 Feb 2013 | Unavailable |
| Start Date | First Received | 1st Completion | Completion | Verification | Results |
|---|
Trial Design
- Allocation: Randomized
- Masking: Single Blind (Subject)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Contacts
- Siu P Sit, PhD
siupo.sit@penumbrainc.com 520 748-3200
- Elan Mualem, BS
elan.mualem@penumbrainc.com 510-748-3200
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Recruitment
- Enrollment: 230
- Gender: Both
- Minimum Age: 18 Years
- Accepts Healthy Volunteers: No
- 8 locations, 1 country
Principal Investigator
- Don Frei, MD
