# 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

> **NCT01584609** · NA · COMPLETED · sponsor: **Penumbra Inc.** · enrollment: 198 (actual)

## Conditions studied

- Acute Ischemic Stroke From Large Vessel Occlusion

## Interventions

- **DEVICE:** Penumbra System with Separator 3D
- **DEVICE:** Penumbra System alone

## Key facts

- **NCT ID:** NCT01584609
- **Lead sponsor:** Penumbra Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-04
- **Primary completion:** 2017-06
- **Final completion:** 2017-12
- **Target enrollment:** 198 (ACTUAL)
- **Last updated:** 2018-09-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01584609

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01584609, "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". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01584609. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*