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

NCT01133223 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-09-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

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)

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)

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Sheila Cristina Ouriques Martins, MD, PhD · Hospital de Clinicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Brazil

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 NCT01133223 on ClinicalTrials.gov