Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
237 participants
INTERVENTIONAL
2007-03-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Percutaneous intervention of the carotid artery
Eligibility Criteria
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Inclusion Criteria
* Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.
Exclusion Criteria
* Planned treatment of contralateral carotid within 30 days.
* Experienced a myocardial infarction within the last 14 days.
* Undergone an angioplasty or PTCA/PTA procedure within the past 48 hours.
* Undergone cardiac surgery within the past 60 days.
* Suffered a stroke within the past 14 days.
* Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
* Abnormal baseline blood counts; platelets \<50,000 or \>700,000/mm3 or WBC count \< 3 x103/uL.
* Intracranial stenosis that exceeded the severity of an extracranial stenosis.
* Total occlusion of the target vessel.
* Lesion within 2cm of the ostium of the common carotid artery.
* A stenosis that is known to be unsuitable for stenting
* Serial lesions that requires more than one stent to cover entire lesion.
18 Years
ALL
No
Sponsors
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Lumen Biomedical
INDUSTRY
Principal Investigators
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J. Michael Bacharach, MD
Role: PRINCIPAL_INVESTIGATOR
Heart Hospital of South Dakota
Subbarao Mylavarapu, MD
Role: PRINCIPAL_INVESTIGATOR
Hoag Hospital
Locations
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Hoag Hospital
Newport Beach, California, United States
Heart Hospital of South Dakota
Sioux Falls, South Dakota, United States
Countries
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Related Links
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Lumen Biomedical website
Other Identifiers
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90-1145
Identifier Type: -
Identifier Source: org_study_id