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

Phase 1

Withdrawn

• Conditions: Stroke; Carotid Stenosis
• Interventions: Procedure: carotid endarterectomy

• Registration Number: NCT00315562
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-14
• Study First Submitted QC: 2006-04-14
• Study First Posted: 2006-04-18
• Status Verified: 2007-03
• Study Completion: 2007-03
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed	carotid endarterectomy	Delayed
Early	carotid endarterectomy	Early

Primary Outcome Measures

Name	Time	Method
modified Rankin Score	90 days

Secondary Outcome Measures

Name	Time	Method
stroke incidence	90 days
transient ischemic attack incidence	90 days

Trial Locations

Locations (1)

UCSD; 🇺🇸 San Diego, California, United States