MedTrace Logo

Assess the Penumbra System in the Treatment of Acute Stroke

NCT01429350 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-09-22

Study results available
· View outcomes & findings →

Summary

The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV rtPA is the only drug approved for the treatment of acute ischemic stroke but it does not work very well in cases where the stroke is caused by a large vessel occlusion. The hypothesis being tested is to determine if the addition of a treatment by a mechanical thrombectomy device like the Penumbra System can improve the clinical outcome of the patient over just using IV rtPA alone.

Conditions

Interventions

DRUG

intravenous (IV) recombinant human tissue plasminogen activator (rtPA)

0.9mg/kg to a maximum of 90mg

DEVICE

Penumbra System

The Penumbra System is an aspiration based mechanical thrombectomy device

Sponsors & Collaborators

  • Penumbra Inc.

    lead INDUSTRY

Principal Investigators

  • J Mocco, MD, MS · Vanderbilt University Medical Center

  • Pooja Khatri, MD · Department of Neurology, University of Cincinnati

  • Osama Zaidat, MD, MSc · Neurointerventional Program, Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01429350 on ClinicalTrials.gov