NCT00334061

Study to Assess the Safety and Effectiveness of the Penumbra System

Evaluation of the Penumbra™ Stroke System in the Revascularization of Patients With Acute Ischemic Stroke Secondary to Intracranial Large Vessel Occlusive Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Penumbra Inc. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This clinical evaluation is a prospective, single-arm, multi-center trial. The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.

Detailed description

Purpose: The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease. Up to 125 evaluable patients will be enrolled in the study.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Penumbra System

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-06-01
• Completion: 2007-11-01
• First posted: 2006-06-06
• Last updated: 2019-09-18
• Results posted: 2009-01-12

Locations

1 site across 1 country: United States