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

This study has been completed.
Sponsor:
Collaborator:
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
  Hide 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.
No text entered.

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  
Number of Participants  
[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
  Show All 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
  Hide 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
No text entered.


  More Information
  Hide 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
e-mail: ck256@georgetown.edu


No publications provided by University of California, Los Angeles

Publications automatically indexed to this study:

Responsible Party: Chelsea S. Kidwell, MD, Georgetown University
ClinicalTrials.gov Identifier: NCT00389467     History of Changes
Obsolete Identifiers: NCT00094588
Other Study ID Numbers: P50NS44378
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