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This study has been withdrawn prior to enrollment.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:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00315562
First received: April 14, 2006
Last updated: February 3, 2015
Last verified: March 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00315562     History of Changes
Other Study ID Numbers: UCSD IRB #060323
Study First Received: April 14, 2006
Last Updated: February 3, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 01, 2015