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

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ClinicalTrials.gov Identifier: NCT00389467
Recruitment Status : Completed
First Posted : October 18, 2006
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
Sponsor:
Collaborator:
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
Enrollment 127
Recruitment Details 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 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.
Arm/Group Title Embolectomy, Penumbral Standard Care, Penumbral Embolectomy, Nonpenumbral Standard Care, Nonpenumbral
Hide Arm/Group Description

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 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 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 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.

Period Title: Overall Study
Started 34 34 30 20
Completed 34 34 30 20
Not Completed 0 0 0 0
Arm/Group Title Embolectomy, Penumbral Standard Care, Penumbral Embolectomy, Nonpenumbral Standard Care, Nonpenumbral Total
Hide Arm/Group Description Treatment assignment = embolectomy, imaging pattern = penumbral Treatment assignment = standard medical care, imaging pattern = penumbral Treatment assignment = embolectomy, imaging pattern = nonpenumbral Treatment assignment = standard medical care, imaging pattern = nonpenumbral Total of all reporting groups
Overall Number of Baseline Participants 34 34 30 20 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 30 participants 20 participants 118 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  47.1%
12
  35.3%
16
  53.3%
7
  35.0%
51
  43.2%
>=65 years
18
  52.9%
22
  64.7%
14
  46.7%
13
  65.0%
67
  56.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 34 participants 30 participants 20 participants 118 participants
66.4  (13.2) 65.8  (16.9) 61.6  (12.0) 69.4  (15.9) 65.5  (14.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 30 participants 20 participants 118 participants
Female
17
  50.0%
19
  55.9%
17
  56.7%
8
  40.0%
61
  51.7%
Male
17
  50.0%
15
  44.1%
13
  43.3%
12
  60.0%
57
  48.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 30 participants 20 participants 118 participants
United States 34 34 30 19 117
Canada 0 0 0 1 1
1.Primary Outcome
Title The Modified Rankin Scale Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embolectomy, Penumbral Standard Care, Penumbral Embolectomy, Nonpenumbral Standard Care, Nonpenumbral
Hide Arm/Group Description:
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 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 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 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%.
Overall Number of Participants Analyzed 34 34 30 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
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)
2.Secondary Outcome
Title Symptomatic Hemorrhagic Transformation
Hide Description

Symptomatic intracranial hemorrhage is defined as 4 point neurologic worsening on the National Institutes of Health Stroke Scale (NIHSS) score associated with parenchymal hematoma type 2 (PH-2*), remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage on imaging. The NIHSS is a scale measuring specific neurologic deficits caused by a stroke with scores ranging from 0 to 42, and higher scores indicating more severe neurologic deficits.

*from the modified European Cooperative Acute Stroke Study (ECASS) II criteria

Time Frame from baseline to day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embolectomy, Penumbral Standard Care, Penumbral Embolectomy, Nonpenumbral Standard Care, Nonpenumbral
Hide Arm/Group Description:
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 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 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 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%.
Overall Number of Participants Analyzed 34 34 30 20
Measure Type: Number
Unit of Measure: participants
3 2 0 0
3.Secondary Outcome
Title Day 90 Mortality
Hide Description [Not Specified]
Time Frame at day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Embolectomy, Penumbral Standard Care, Penumbral Embolectomy, Nonpenumbral Standard Care, Nonpenumbral
Hide Arm/Group Description:
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 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 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 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%.
Overall Number of Participants Analyzed 34 34 30 20
Measure Type: Number
Unit of Measure: participants
6 7 6 6
Time Frame [Not Specified]
Adverse Event Reporting Description Other Adverse Events were not collected.
 
Arm/Group Title Total Cohort Embolectomy, Penumbral Standard Care, Penumbral Embolectomy, Nonpenumbral Standard Care, Nonpenumbral
Hide Arm/Group Description [Not Specified] 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 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 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 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%.
All-Cause Mortality
Total Cohort Embolectomy, Penumbral Standard Care, Penumbral Embolectomy, Nonpenumbral Standard Care, Nonpenumbral
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Total Cohort Embolectomy, Penumbral Standard Care, Penumbral Embolectomy, Nonpenumbral Standard Care, Nonpenumbral
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   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  1/118 (0.85%)  1 0/34 (0.00%)  0 0/34 (0.00%)  0 1/30 (3.33%)  1 0/20 (0.00%)  0
Anemia  1/118 (0.85%)  1 0/34 (0.00%)  0 0/34 (0.00%)  0 0/30 (0.00%)  0 1/20 (5.00%)  1
Cardiac disorders           
Cardiac  9/118 (7.63%)  11 4/34 (11.76%)  5 2/34 (5.88%)  3 2/30 (6.67%)  2 1/20 (5.00%)  1
Gastrointestinal disorders           
Gastrointestinal  3/118 (2.54%)  4 0/34 (0.00%)  0 1/34 (2.94%)  1 2/30 (6.67%)  3 0/20 (0.00%)  0
General disorders           
Death  24/118 (20.34%)  24 5/34 (14.71%)  5 7/34 (20.59%)  7 6/30 (20.00%)  6 6/20 (30.00%)  6
Infections and infestations           
Infectious  5/118 (4.24%)  5 1/34 (2.94%)  1 2/34 (5.88%)  2 0/30 (0.00%)  0 2/20 (10.00%)  2
Musculoskeletal and connective tissue disorders           
Psoas Hematoma  1/118 (0.85%)  1 0/34 (0.00%)  0 0/34 (0.00%)  0 1/30 (3.33%)  1 0/20 (0.00%)  0
Nervous system disorders           
Neurological worsening or cerebral edema  39/118 (33.05%)  41 11/34 (32.35%)  11 6/34 (17.65%)  6 15/30 (50.00%)  17 7/20 (35.00%)  7
Procedural Complications  7/64 (10.94%)  7 5/34 (14.71%)  5 0/34 (0.00%)  0 2/30 (6.67%)  2 0/20 (0.00%)  0
New Stroke  6/118 (5.08%)  6 4/34 (11.76%)  4 0/34 (0.00%)  0 2/30 (6.67%)  2 0/20 (0.00%)  0
Symptomatic Hemorrhage  5/118 (4.24%)  5 1/34 (2.94%)  1 2/34 (5.88%)  2 0/30 (0.00%)  0 2/20 (10.00%)  2
Seizure  1/118 (0.85%)  1 1/34 (2.94%)  1 0/34 (0.00%)  0 0/30 (0.00%)  0 0/20 (0.00%)  0
Asymptomatic Hemorrhage  4/118 (3.39%)  4 3/34 (8.82%)  3 0/34 (0.00%)  0 1/30 (3.33%)  1 0/20 (0.00%)  0
Renal and urinary disorders           
Renal  3/118 (2.54%)  3 0/34 (0.00%)  0 1/34 (2.94%)  1 0/30 (0.00%)  0 2/20 (10.00%)  2
Respiratory, thoracic and mediastinal disorders           
Respiratory  9/118 (7.63%)  10 2/34 (5.88%)  2 0/34 (0.00%)  0 5/30 (16.67%)  6 2/20 (10.00%)  2
Surgical and medical procedures           
Amputation  1/118 (0.85%)  1 0/34 (0.00%)  0 0/34 (0.00%)  0 0/30 (0.00%)  0 1/20 (5.00%)  1
Vascular disorders           
DVT  2/118 (1.69%)  2 1/34 (2.94%)  1 0/34 (0.00%)  0 0/30 (0.00%)  0 1/20 (5.00%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total Cohort Embolectomy, Penumbral Standard Care, Penumbral Embolectomy, Nonpenumbral Standard Care, Nonpenumbral
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0      0/0      0/0      0/0    
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
Responsible Party: Chelsea S. Kidwell, MD, Georgetown University
ClinicalTrials.gov 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