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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Penumbra Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke From Large Vessel Occlusion

Interventions

Type	Name	Description
DEVICE	Penumbra System with Separator 3D	The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
DEVICE	Penumbra System alone	The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.

Timeline

• Start date: 2012-04-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2012-04-25
• Last updated: 2018-09-13
• Results posted: 2018-09-13

Locations

8 sites across 1 country: United States