CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 125 enrolled
Drug / intervention
Penumbra Systemdevice
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Clinical signs consistent with acute ischemic stroke
  • ✓Age 18 to 79 years
  • ✓NIHSS score >8 (neurological deficit)
  • ✓TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System
Key exclusion· 16
  • ✕Rapidly improving neurological signs at enrollment
  • ✕NIHSS >30 or coma
  • ✕Pregnant females
  • ✕Vessel tortuosity too difficult for endovascular access

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00334061
NCT00334061Phase 2Completed
CompareCT.gov

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

Penumbra Inc.·interventional·Posted Jun 6, 2006·Updated Sep 18, 2019

In Brief

A Phase 2 clinical trial evaluating Penumbra System for Stroke. Completed, enrolled 125 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2006
Enrollment StartJun 1, 2006
Primary CompletionJun 1, 2007
Study CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 20.1 years ago

Interventions

Penumbra Systemdevice