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

February 3, 2015 updated by: University of California, San Diego

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • UCSD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early
Procedure: carotid endarterectomy
Active Comparator: Delayed
Procedure: carotid endarterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
modified Rankin Score
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
stroke incidence
Time Frame: 90 days
90 days
transient ischemic attack incidence
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Matt B Jensen, MD, UCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

April 14, 2006

First Submitted That Met QC Criteria

April 14, 2006

First Posted (Estimate)

April 18, 2006

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSD IRB #060323

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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