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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From 2004 to 2011, participants were enrolled at 22 sites with expertise in acute stroke care, imaging and interventional neuroradiological procedures. Eligible patients presenting within 8 hours of symptom onset were enrolled. The study website generated a randomized treatment assignment using a penumbral pattern code based on brain imaging.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization was stratified by favorable penumbral or non-penumbral pattern based on on-site analysis of baseline multimodal MRI or multimodal CT. While 127 subjects were enrolled, only 118 of these subjects qualified for the primary analysis per discussion with the DSMB as 9 subjects enrolled did not actually meet full eligibility criteria.

Reporting Groups
  Description
Embolectomy, Penumbral

Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.

Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset.

Standard Care, Penumbral

Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.

Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset.

Embolectomy, Nonpenumbral

Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.

Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset.

Standard Care, Nonpenumbral

Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.

Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset.


Participant Flow:   Overall Study
    Embolectomy, Penumbral     Standard Care, Penumbral     Embolectomy, Nonpenumbral     Standard Care, Nonpenumbral  
STARTED     34     34     30     20  
COMPLETED     34     34     30     20  
NOT COMPLETED     0     0     0     0  



  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.
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
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1.  Primary:   The Modified Rankin Scale Score   [ Time Frame: at 90 days post-stroke ]
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Measure Type Primary
Measure Title The Modified Rankin Scale Score
Measure Description

Scale name is provided (Modified Rankin Scale) which is a standard measure of functional neurologic outcome in stroke. The scale runs from 0-6, running from perfect health without symptoms to death.

  • 0 - No symptoms.
  • 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.
  • 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  • 3 - Moderate disability. Requires some help, but able to walk unassisted.
  • 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  • 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  • 6 - Dead.
Time Frame at 90 days post-stroke  
Safety Issue No  

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 Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
Standard Care, Penumbral Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
Embolectomy, Nonpenumbral Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
Standard Care, Nonpenumbral Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.

Measured Values
    Embolectomy, Penumbral     Standard Care, Penumbral     Embolectomy, Nonpenumbral     Standard Care, Nonpenumbral  
Number of Participants Analyzed  
[units: participants]
  34     34     30     20  
The Modified Rankin Scale Score  
[units: units on a scale]
Mean ( 95% Confidence Interval )
  3.9  
  ( 3.3 to 4.4 )  
  3.4  
  ( 2.8 to 4.0 )  
  4.0  
  ( 3.4 to 4.6 )  
  4.4  
  ( 3.6 to 5.2 )  

No statistical analysis provided for The Modified Rankin Scale Score



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
No text entered.


  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


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