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Study of Early Versus Delayed Carotid Endarterectomy (CEA) for Small to Medium-sized Ischemic Stroke Caused by High-grade Carotid Stenosis

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00315562
First Posted: April 18, 2006
Last Update Posted: February 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, San Diego
  Purpose
Pilot study of early versus delayed carotid endarterectomy (CEA) for small to medium-sized ischemic stroke caused by high-grade carotid stenosis.

Condition Intervention Phase
Stroke Carotid Stenosis Procedure: carotid endarterectomy Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Early Versus Delayed Carotid Endarterectomy (CEA) for Small to Medium-sized Ischemic Stroke Caused by High-grade Carotid Stenosis

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • modified Rankin Score [ Time Frame: 90 days ]

Secondary Outcome Measures:
  • stroke incidence [ Time Frame: 90 days ]
  • transient ischemic attack incidence [ Time Frame: 90 days ]

Enrollment: 0
Study Start Date: April 2006
Study Completion Date: March 2007
Arms Assigned Interventions
Experimental: Early
Early
Procedure: carotid endarterectomy
Active Comparator: Delayed
Delayed
Procedure: carotid endarterectomy

Detailed Description:
Pilot study of early versus delayed carotid endarterectomy (CEA) for small to medium-sized ischemic stroke caused by high-grade carotid stenosis.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 and older.
  • New small to medium-sized ischemic stroke (defined as less than 1/3 of the MCA territory) in the territory of 70% or greater carotid stenosis.
  • Women of child-bearing potential will be included only if there is a negative pregnancy test and they agree to birth control during the treatment period.

Exclusion Criteria:

  • Patients judged to be a poor surgical candidate by the treating physicians.
  • Unstable neurological status.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315562


Locations
United States, California
UCSD
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Matt B Jensen, MD UCSD
  More Information

ClinicalTrials.gov Identifier: NCT00315562     History of Changes
Other Study ID Numbers: UCSD IRB #060323
First Submitted: April 14, 2006
First Posted: April 18, 2006
Last Update Posted: February 4, 2015
Last Verified: March 2007

Keywords provided by University of California, San Diego:
stroke
carotid stenosis
carotid endarterectomy
timing

Additional relevant MeSH terms:
Stroke
Constriction, Pathologic
Carotid Stenosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Carotid Artery Diseases
Arterial Occlusive Diseases