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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01133223
First Posted: May 28, 2010
Last Update Posted: September 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lucas Scotta Cabral, Hospital de Clinicas de Porto Alegre
  Purpose
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.

Condition Intervention Phase
Stroke Device: Penumbra™ System Drug: Recombinant tissue plasminogen activator Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Intravenous Thrombolysis With Thrombectomy by the Penumbra™ System in Patients With Middle Cerebral Artery Stem Occlusion - Pilot Study

Further study details as provided by Lucas Scotta Cabral, Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Functional independence (modified Rankin Scale 0-2) [ Time Frame: 3 months ]

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

Enrollment: 0
Study Start Date: May 2010
Estimated Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133223


Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Sheila Cristina Ouriques Martins, MD, PhD Hospital de Clinicas de Porto Alegre
  More Information

Publications:

Responsible Party: Lucas Scotta Cabral, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01133223     History of Changes
Other Study ID Numbers: GPPG 09-587
First Submitted: May 26, 2010
First Posted: May 28, 2010
Last Update Posted: September 3, 2015
Last Verified: September 2015

Keywords provided by Lucas Scotta Cabral, Hospital de Clinicas de Porto Alegre:
Stroke, mecanical thrombectomy

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action