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

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. Identifier: NCT00389467
Recruitment Status : Completed
First Posted : October 18, 2006
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Chelsea S. Kidwell, MD, Georgetown University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stroke
Intervention: Device: Merci Retriever and Penumbra System

  Participant Flow

  Baseline Characteristics

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
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 
[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 
[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) 
[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

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

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

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

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

Responsible Party: Chelsea S. Kidwell, MD, Georgetown University Identifier: NCT00389467     History of Changes
Obsolete Identifiers: NCT00094588
Other Study ID Numbers: P50NS044378 ( U.S. NIH Grant/Contract )
First Submitted: October 16, 2006
First Posted: October 18, 2006
Results First Submitted: April 12, 2013
Results First Posted: March 26, 2014
Last Update Posted: March 26, 2014