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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00315562
Other study ID # UCSD IRB #060323
Secondary ID
Status Withdrawn
Phase Phase 1
First received April 14, 2006
Last updated February 3, 2015
Start date April 2006
Est. completion date March 2007

Study information

Verified date March 2007
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
carotid endarterectomy


Locations

Country Name City State
United States UCSD San Diego California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary modified Rankin Score 90 days
Secondary stroke incidence 90 days
Secondary transient ischemic attack incidence 90 days
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