Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Penumbra.
NCT01584609 is a NA study that has completed, run by Penumbra. The registered enrollment target is 198 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of Participants with Angiographic revascularization of the occluded target vessel defined by mTICI grade 2-3
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 |
What the finished NCT01584609 record still lists
NCT01584609 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Penumbra System with Separator 3D is the first listed.
NCT01584609 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01584609's enrollment target sits among peer trials
198 567th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05203328 · 198 participants · NA
Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care During EBUS Bronchoscopy
- NCT05426967 · 198 participants · NA
rTMS for Military TBI-related Depression
- NCT05561114 · 198 participants · Phase 3
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
- NCT05585190 · 198 participants · NA
Stand Up for Your Health with a Sit-stand Desk
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia