Carotid Occlusion Surgery Study (COSS)
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ClinicalTrials.gov Identifier: NCT00029146 |
Recruitment Status :
Terminated
(Pre-specified futility boundary was reached.)
First Posted : January 9, 2002
Results First Posted : March 26, 2012
Last Update Posted : March 27, 2012
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Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Washington University School of Medicine
University of Iowa
Information provided by (Responsible Party):
William Powers, University of North Carolina, Chapel Hill
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Stroke Ischemic Attack, Transient Cerebral Infarction |
Interventions |
Procedure: extracranial-intracranial bypass surgery Drug: best medical therapy |
Enrollment | 700 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Surgical Group | Non-surgical Group |
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Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy | Receives best current practice medical therapy |
Period Title: Overall Study | ||
Started | 97 | 98 |
Completed | 95 | 97 |
Not Completed | 2 | 1 |
Reason Not Completed | ||
Lost to Follow-up | 2 | 1 |
Baseline Characteristics
Arm/Group Title | Surgical Group | Non-surgical Group | Total | |
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Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy | Receives best current practice medical therapy | Total of all reporting groups | |
Overall Number of Baseline Participants | 97 | 98 | 195 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 97 participants | 98 participants | 195 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
76 78.4%
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71 72.4%
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147 75.4%
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>=65 years |
21 21.6%
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27 27.6%
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48 24.6%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 97 participants | 98 participants | 195 participants | |
58 (9) | 58 (9) | 58 (9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 97 participants | 98 participants | 195 participants | |
Female |
28 28.9%
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37 37.8%
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65 33.3%
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Male |
69 71.1%
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61 62.2%
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130 66.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 97 participants | 98 participants | 195 participants |
United States | 93 | 94 | 187 | |
Canada | 4 | 4 | 8 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | William J. Powers, MD |
Organization: | University of North Carolina at Chapel HIll |
EMail: | powersw@neurology.unc.edu |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | William Powers, University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00029146 |
Other Study ID Numbers: |
R01NS042167 R01NS041895 ( Other Grant/Funding Number: NINDS ) |
First Submitted: | January 8, 2002 |
First Posted: | January 9, 2002 |
Results First Submitted: | January 17, 2012 |
Results First Posted: | March 26, 2012 |
Last Update Posted: | March 27, 2012 |