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Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Chelsea S. Kidwell, MD, Georgetown University
ClinicalTrials.gov Identifier:
NCT00389467
First received: October 16, 2006
Last updated: February 26, 2014
Last verified: February 2014
Results First Received: April 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stroke
Intervention: Device: Merci Retriever and Penumbra System

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Embolectomy, Penumbral Treatment assignment = embolectomy, imaging pattern = penumbral
Standard Care, Penumbral Treatment assignment = standard medical care, imaging pattern = penumbral
Embolectomy, Nonpenumbral Treatment assignment = embolectomy, imaging pattern = nonpenumbral
Standard Care, Nonpenumbral Treatment assignment = standard medical care, imaging pattern = nonpenumbral
Total Total of all reporting groups

Baseline Measures
   Embolectomy, Penumbral   Standard Care, Penumbral   Embolectomy, Nonpenumbral   Standard Care, Nonpenumbral   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   34   30   20   118 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   16   12   16   7   51 
>=65 years   18   22   14   13   67 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.4  (13.2)   65.8  (16.9)   61.6  (12.0)   69.4  (15.9)   65.5  (14.6) 
Gender 
[Units: Participants]
         
Female   17   19   17   8   61 
Male   17   15   13   12   57 
Region of Enrollment 
[Units: Participants]
         
United States   34   34   30   19   117 
Canada   0   0   0   1   1 


  Outcome Measures
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1.  Primary:   The Modified Rankin Scale Score   [ Time Frame: at 90 days post-stroke ]

2.  Secondary:   Symptomatic Hemorrhagic Transformation   [ Time Frame: from baseline to day 7 ]

3.  Secondary:   Day 90 Mortality   [ Time Frame: at day 90 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chelsea S. Kidwell, MD
Organization: Georgetown University
phone: 202-687-7302
e-mail: ck256@georgetown.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chelsea S. Kidwell, MD, Georgetown University
ClinicalTrials.gov Identifier: NCT00389467     History of Changes
Obsolete Identifiers: NCT00094588
Other Study ID Numbers: P50NS044378 ( US NIH Grant/Contract Award Number )
Study First Received: October 16, 2006
Results First Received: April 12, 2013
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration