Study to Assess the Safety and Effectiveness of the Penumbra System

Completed

Phase 2 Results

Trial Description

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

Interventions

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

Patient has mechanical thrombectomy using Penumbra system. Return for follow-up testing at 30 and 90 days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Revascularization of the occluded target vessel; incidence of device-related and procedure-related serious adverse events.
Secondary The proportion of patients who have either a 4-point improvement on the National Institutes of Health Stroke Scale (NIHSS) at discharge or a modified Rankin Scale (mRS) score of ? 2 at 30 days after treatment; the proportion of patients with a modified Rankin Scale (mRS) score of ? 2 at 90 days post treatment; all cause mortality; incidence of symptomatic hemorrhage.
Primary Percentage of Participants With Revascularization of the Occluded Target Vessel 6-Month Post-Procedure No
Primary Percentage of Participants With Device-Related and Procedure-Related Serious Adverse Events 6-Month Post-Procedure Yes
Secondary Percentage of Participants With Either a 4-Point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment Discharge or 30-Days Post-Procedure No
Secondary Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment 90-Day Yes
Secondary Percentage of Participants With All Cause Mortality 90-Days Post-Treatment Yes
Secondary Percentage of Participants With Symptomatic Hemorrhage 24-Hour Post-Procedure Yes

Sponsors