Safety and Efficacy of the Penumbra™ System in Acute Middle Cerebral Artery (MCA) Stroke

September 2, 2015 updated by: Lucas Scotta Cabral, Hospital de Clinicas de Porto Alegre

Randomized Clinical Trial Comparing Intravenous Thrombolysis With Thrombectomy by the Penumbra™ System in Patients With Middle Cerebral Artery Stem Occlusion - Pilot Study

Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be achieved with different strategies - varying from intravenous rtPA from mechanical thrombectomy. Recently, interventional approaches have been gaining attention and playing an increasing role in stroke care. However, no solid scientifical data is available to date. The investigators want do conduct a pilot trial to test if the use of the Penumbra™ System can improve clinical outcomes in a specific stroke setting.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient enrolled in acute ischemic stroke protocol
  • Up to 3,5h from symptoms onset
  • Clinical findings compatible with middle cerebral artery syndrome
  • Angiotomographic evidence of proximal middle cerebral artery occlusion

Exclusion Criteria:

  • NIHSS < 10
  • Overt contraindication to thrombolysis or angiopgraphy
  • Disagreement with informed consent term or refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care
Drug: Recombinant tissue plasminogen activator
Patients assigned to Usual Care arm will be thrombolysed according to the NINDS protocol (rtPA 0,9 mg/kg, 10% IV bolus and remaining in the next hour, up to 90 mg)
Active Comparator: Thrombectomy
Device: Penumbra™ System
Patients assigned to the Thrombectomy arm will be conducted to the angio suite. Mechanical thrombectomy will be attempted with the use of the Penumbra™ System, and can be assisted by intraarterial thrombolysis (rTPA up to 20 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional independence (modified Rankin Scale 0-2)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Minimal or no disability (modified Rankin Scale 0-1)
Time Frame: 3 months
3 months
Overall mortality
Time Frame: 7 days and 3 months
7 days and 3 months
Symptomatic cerebral bleeding rate
Time Frame: 48 hours, 7 days and 3 months
48 hours, 7 days and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Sheila Cristina Ouriques Martins, MD, PhD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Estimate)

September 3, 2015

Last Update Submitted That Met QC Criteria

September 2, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPPG 09-587

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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