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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

Primary Purpose

Stroke, Carotid Stenosis

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carotid endarterectomy
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, carotid stenosis, carotid endarterectomy, timing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early

Delayed

Arm Description

Early

Delayed

Outcomes

Primary Outcome Measures

modified Rankin Score

Secondary Outcome Measures

stroke incidence
transient ischemic attack incidence

Full Information

First Posted
April 14, 2006
Last Updated
February 3, 2015
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00315562
Brief Title
Study of Early Versus Delayed Carotid Endarterectomy (CEA) for Small to Medium-sized Ischemic Stroke Caused by High-grade Carotid Stenosis
Official Title
Pilot Study of Early Versus Delayed Carotid Endarterectomy (CEA) for Small to Medium-sized Ischemic Stroke Caused by High-grade Carotid Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Withdrawn
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Diego

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Carotid Stenosis
Keywords
stroke, carotid stenosis, carotid endarterectomy, timing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early
Arm Type
Experimental
Arm Description
Early
Arm Title
Delayed
Arm Type
Active Comparator
Arm Description
Delayed
Intervention Type
Procedure
Intervention Name(s)
carotid endarterectomy
Primary Outcome Measure Information:
Title
modified Rankin Score
Time Frame
90 days
Secondary Outcome Measure Information:
Title
stroke incidence
Time Frame
90 days
Title
transient ischemic attack incidence
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt B Jensen, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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