Trial Outcomes & Findings for Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (NCT NCT00389467)

Last Updated: 2014-03-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

127 participants

Primary outcome timeframe

at 90 days post-stroke

Results posted on

2014-03-26

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	34	34	30	20
Overall Study COMPLETED	34	34	30	20
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Embolectomy, Penumbral n=34 Participants Treatment assignment = embolectomy, imaging pattern = penumbral	Standard Care, Penumbral n=34 Participants Treatment assignment = standard medical care, imaging pattern = penumbral	Embolectomy, Nonpenumbral n=30 Participants Treatment assignment = embolectomy, imaging pattern = nonpenumbral	Standard Care, Nonpenumbral n=20 Participants Treatment assignment = standard medical care, imaging pattern = nonpenumbral	Total n=118 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants	7 Participants n=4 Participants	51 Participants n=21 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	22 Participants n=7 Participants	14 Participants n=5 Participants	13 Participants n=4 Participants	67 Participants n=21 Participants
Age, Continuous	66.4 years STANDARD_DEVIATION 13.2 • n=5 Participants	65.8 years STANDARD_DEVIATION 16.9 • n=7 Participants	61.6 years STANDARD_DEVIATION 12.0 • n=5 Participants	69.4 years STANDARD_DEVIATION 15.9 • n=4 Participants	65.5 years STANDARD_DEVIATION 14.6 • n=21 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	19 Participants n=7 Participants	17 Participants n=5 Participants	8 Participants n=4 Participants	61 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	12 Participants n=4 Participants	57 Participants n=21 Participants
Region of Enrollment United States	34 participants n=5 Participants	34 participants n=7 Participants	30 participants n=5 Participants	19 participants n=4 Participants	117 participants n=21 Participants
Region of Enrollment Canada	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants

PRIMARY outcome

Timeframe: at 90 days post-stroke

Outcome measures

Outcome measures
Measure	Embolectomy, Penumbral n=34 Participants 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 n=34 Participants 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 n=30 Participants 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 n=20 Participants 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%.
The Modified Rankin Scale Score	3.9 units on a scale Interval 3.3 to 4.4	3.4 units on a scale Interval 2.8 to 4.0	4.0 units on a scale Interval 3.4 to 4.6	4.4 units on a scale Interval 3.6 to 5.2

SECONDARY outcome

Timeframe: from baseline to day 7

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

Outcome measures

Outcome measures
Measure	Embolectomy, Penumbral n=34 Participants 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 n=34 Participants 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 n=30 Participants 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 n=20 Participants 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%.
Symptomatic Hemorrhagic Transformation	3 participants	2 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: at day 90

Outcome measures

Outcome measures
Measure	Embolectomy, Penumbral n=34 Participants 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 n=34 Participants 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 n=30 Participants 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 n=20 Participants 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%.
Day 90 Mortality	6 participants	7 participants	6 participants	6 participants

Adverse Events

Total Cohort

Serious events: 74 serious events

Other events: 0 other events

Deaths: 0 deaths

Embolectomy, Penumbral

Serious events: 25 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care, Penumbral

Serious events: 15 serious events

Other events: 0 other events

Deaths: 0 deaths

Embolectomy, Nonpenumbral

Serious events: 22 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care, Nonpenumbral

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Total Cohort n=118 participants at risk	Embolectomy, Penumbral n=34 participants at risk 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 n=34 participants at risk 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 n=30 participants at risk 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 n=20 participants at risk 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%.
Nervous system disorders Neurological worsening or cerebral edema	33.1% 39/118 • Number of events 41 Other Adverse Events were not collected.	32.4% 11/34 • Number of events 11 Other Adverse Events were not collected.	17.6% 6/34 • Number of events 6 Other Adverse Events were not collected.	50.0% 15/30 • Number of events 17 Other Adverse Events were not collected.	35.0% 7/20 • Number of events 7 Other Adverse Events were not collected.
Nervous system disorders Procedural Complications	10.9% 7/64 • Number of events 7 Other Adverse Events were not collected.	14.7% 5/34 • Number of events 5 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	6.7% 2/30 • Number of events 2 Other Adverse Events were not collected.	0.00% 0/20 Other Adverse Events were not collected.
Respiratory, thoracic and mediastinal disorders Respiratory	7.6% 9/118 • Number of events 10 Other Adverse Events were not collected.	5.9% 2/34 • Number of events 2 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	16.7% 5/30 • Number of events 6 Other Adverse Events were not collected.	10.0% 2/20 • Number of events 2 Other Adverse Events were not collected.
Cardiac disorders Cardiac	7.6% 9/118 • Number of events 11 Other Adverse Events were not collected.	11.8% 4/34 • Number of events 5 Other Adverse Events were not collected.	5.9% 2/34 • Number of events 3 Other Adverse Events were not collected.	6.7% 2/30 • Number of events 2 Other Adverse Events were not collected.	5.0% 1/20 • Number of events 1 Other Adverse Events were not collected.
Nervous system disorders New Stroke	5.1% 6/118 • Number of events 6 Other Adverse Events were not collected.	11.8% 4/34 • Number of events 4 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	6.7% 2/30 • Number of events 2 Other Adverse Events were not collected.	0.00% 0/20 Other Adverse Events were not collected.
Infections and infestations Infectious	4.2% 5/118 • Number of events 5 Other Adverse Events were not collected.	2.9% 1/34 • Number of events 1 Other Adverse Events were not collected.	5.9% 2/34 • Number of events 2 Other Adverse Events were not collected.	0.00% 0/30 Other Adverse Events were not collected.	10.0% 2/20 • Number of events 2 Other Adverse Events were not collected.
Nervous system disorders Symptomatic Hemorrhage	4.2% 5/118 • Number of events 5 Other Adverse Events were not collected.	2.9% 1/34 • Number of events 1 Other Adverse Events were not collected.	5.9% 2/34 • Number of events 2 Other Adverse Events were not collected.	0.00% 0/30 Other Adverse Events were not collected.	10.0% 2/20 • Number of events 2 Other Adverse Events were not collected.
Gastrointestinal disorders Gastrointestinal	2.5% 3/118 • Number of events 4 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	2.9% 1/34 • Number of events 1 Other Adverse Events were not collected.	6.7% 2/30 • Number of events 3 Other Adverse Events were not collected.	0.00% 0/20 Other Adverse Events were not collected.
Renal and urinary disorders Renal	2.5% 3/118 • Number of events 3 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	2.9% 1/34 • Number of events 1 Other Adverse Events were not collected.	0.00% 0/30 Other Adverse Events were not collected.	10.0% 2/20 • Number of events 2 Other Adverse Events were not collected.
Vascular disorders DVT	1.7% 2/118 • Number of events 2 Other Adverse Events were not collected.	2.9% 1/34 • Number of events 1 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	0.00% 0/30 Other Adverse Events were not collected.	5.0% 1/20 • Number of events 1 Other Adverse Events were not collected.
Nervous system disorders Seizure	0.85% 1/118 • Number of events 1 Other Adverse Events were not collected.	2.9% 1/34 • Number of events 1 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	0.00% 0/30 Other Adverse Events were not collected.	0.00% 0/20 Other Adverse Events were not collected.
Blood and lymphatic system disorders Heparin Induced Thrombocytopenia	0.85% 1/118 • Number of events 1 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	3.3% 1/30 • Number of events 1 Other Adverse Events were not collected.	0.00% 0/20 Other Adverse Events were not collected.
Musculoskeletal and connective tissue disorders Psoas Hematoma	0.85% 1/118 • Number of events 1 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	3.3% 1/30 • Number of events 1 Other Adverse Events were not collected.	0.00% 0/20 Other Adverse Events were not collected.
Blood and lymphatic system disorders Anemia	0.85% 1/118 • Number of events 1 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	0.00% 0/30 Other Adverse Events were not collected.	5.0% 1/20 • Number of events 1 Other Adverse Events were not collected.
Surgical and medical procedures Amputation	0.85% 1/118 • Number of events 1 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	0.00% 0/30 Other Adverse Events were not collected.	5.0% 1/20 • Number of events 1 Other Adverse Events were not collected.
General disorders Death	20.3% 24/118 • Number of events 24 Other Adverse Events were not collected.	14.7% 5/34 • Number of events 5 Other Adverse Events were not collected.	20.6% 7/34 • Number of events 7 Other Adverse Events were not collected.	20.0% 6/30 • Number of events 6 Other Adverse Events were not collected.	30.0% 6/20 • Number of events 6 Other Adverse Events were not collected.
Nervous system disorders Asymptomatic Hemorrhage	3.4% 4/118 • Number of events 4 Other Adverse Events were not collected.	8.8% 3/34 • Number of events 3 Other Adverse Events were not collected.	0.00% 0/34 Other Adverse Events were not collected.	3.3% 1/30 • Number of events 1 Other Adverse Events were not collected.	0.00% 0/20 Other Adverse Events were not collected.

Other adverse events

Adverse event data not reported

Additional Information

Chelsea S. Kidwell, MD

Georgetown University

Phone: 202-687-7302

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place