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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
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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 
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
  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
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Time Frame No text entered.
Additional Description Other Adverse Events were not collected.

Reporting Groups
  Description
Total Cohort No text entered.
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%.

Serious Adverse Events
    Total Cohort   Embolectomy, Penumbral   Standard Care, Penumbral   Embolectomy, Nonpenumbral   Standard Care, Nonpenumbral
Total, serious adverse events           
# participants affected / at risk   74/118 (62.71%)   25/34 (73.53%)   15/34 (44.12%)   22/30 (73.33%)   12/20 (60.00%) 
Blood and lymphatic system disorders           
Heparin Induced Thrombocytopenia           
# participants affected / at risk   1/118 (0.85%)   0/34 (0.00%)   0/34 (0.00%)   1/30 (3.33%)   0/20 (0.00%) 
# events   1   0   0   1   0 
Anemia           
# participants affected / at risk   1/118 (0.85%)   0/34 (0.00%)   0/34 (0.00%)   0/30 (0.00%)   1/20 (5.00%) 
# events   1   0   0   0   1 
Cardiac disorders           
Cardiac           
# participants affected / at risk   9/118 (7.63%)   4/34 (11.76%)   2/34 (5.88%)   2/30 (6.67%)   1/20 (5.00%) 
# events   11   5   3   2   1 
Gastrointestinal disorders           
Gastrointestinal           
# participants affected / at risk   3/118 (2.54%)   0/34 (0.00%)   1/34 (2.94%)   2/30 (6.67%)   0/20 (0.00%) 
# events   4   0   1   3   0 
General disorders           
Death           
# participants affected / at risk   24/118 (20.34%)   5/34 (14.71%)   7/34 (20.59%)   6/30 (20.00%)   6/20 (30.00%) 
# events   24   5   7   6   6 
Infections and infestations           
Infectious           
# participants affected / at risk   5/118 (4.24%)   1/34 (2.94%)   2/34 (5.88%)   0/30 (0.00%)   2/20 (10.00%) 
# events   5   1   2   0   2 
Musculoskeletal and connective tissue disorders           
Psoas Hematoma           
# participants affected / at risk   1/118 (0.85%)   0/34 (0.00%)   0/34 (0.00%)   1/30 (3.33%)   0/20 (0.00%) 
# events   1   0   0   1   0 
Nervous system disorders           
Neurological worsening or cerebral edema           
# participants affected / at risk   39/118 (33.05%)   11/34 (32.35%)   6/34 (17.65%)   15/30 (50.00%)   7/20 (35.00%) 
# events   41   11   6   17   7 
Procedural Complications           
# participants affected / at risk   7/64 (10.94%)   5/34 (14.71%)   0/34 (0.00%)   2/30 (6.67%)   0/20 (0.00%) 
# events   7   5   0   2   0 
New Stroke           
# participants affected / at risk   6/118 (5.08%)   4/34 (11.76%)   0/34 (0.00%)   2/30 (6.67%)   0/20 (0.00%) 
# events   6   4   0   2   0 
Symptomatic Hemorrhage           
# participants affected / at risk   5/118 (4.24%)   1/34 (2.94%)   2/34 (5.88%)   0/30 (0.00%)   2/20 (10.00%) 
# events   5   1   2   0   2 
Seizure           
# participants affected / at risk   1/118 (0.85%)   1/34 (2.94%)   0/34 (0.00%)   0/30 (0.00%)   0/20 (0.00%) 
# events   1   1   0   0   0 
Asymptomatic Hemorrhage           
# participants affected / at risk   4/118 (3.39%)   3/34 (8.82%)   0/34 (0.00%)   1/30 (3.33%)   0/20 (0.00%) 
# events   4   3   0   1   0 
Renal and urinary disorders           
Renal           
# participants affected / at risk   3/118 (2.54%)   0/34 (0.00%)   1/34 (2.94%)   0/30 (0.00%)   2/20 (10.00%) 
# events   3   0   1   0   2 
Respiratory, thoracic and mediastinal disorders           
Respiratory           
# participants affected / at risk   9/118 (7.63%)   2/34 (5.88%)   0/34 (0.00%)   5/30 (16.67%)   2/20 (10.00%) 
# events   10   2   0   6   2 
Surgical and medical procedures           
Amputation           
# participants affected / at risk   1/118 (0.85%)   0/34 (0.00%)   0/34 (0.00%)   0/30 (0.00%)   1/20 (5.00%) 
# events   1   0   0   0   1 
Vascular disorders           
DVT           
# participants affected / at risk   2/118 (1.69%)   1/34 (2.94%)   0/34 (0.00%)   0/30 (0.00%)   1/20 (5.00%) 
# events   2   1   0   0   1 




  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


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