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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01133223
First received: May 26, 2010
Last updated: May 27, 2010
Last verified: May 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Alteplase
U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Functional independence (modified Rankin Scale 0-2) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133223

Contacts
Contact: Sheila Cristina Ouriques Martins, MD, PhD smartins@portoweb.com.br

Locations
Brazil
Hospital de Clinicas de Porto Alegre Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Principal Investigator: Lucas Scotta Cabral, MD            
Principal Investigator: Sheila Cristina Ouriques Martins, MD, PhD            
Sub-Investigator: Rosane Brondani, MD, MsC            
Sub-Investigator: Andrea Garcia Almeida, MD            
Sub-Investigator: Marco Antonio Stefani, MD, PhD            
Sub-Investigator: Paulo Passos, MD            
Sub-Investigator: Eduardo Raupp, MD            
Sub-Investigator: Márcia Chaves, MD, PhD            
Sub-Investigator: Leonardo Vedolin, MD, PhD            
Sub-Investigator: Mariangela Friedrich, MD            
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: Sheila Cristina Ouriques Martins, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01133223     History of Changes
Other Study ID Numbers: GPPG 09-587
Study First Received: May 26, 2010
Last Updated: May 27, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
 Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on May 19, 2013