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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00967486
Date of registration: 27/08/2009
Prospective Registration: No
Primary sponsor: CAMC Health System
Public title: Selective Versus Routine Shunting in Carotid Endarterectomy Patients
Scientific title: Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure
Date of first enrolment: December 2006
Target sample size: 200
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00967486
Study type:  Interventional
Study design:   
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Ali F AbuRhama, M.D.
Address: 
Telephone:
Email:
Affiliation:  CAMC Medical Staff - with admitting privileges
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with a SP >= 50 mmHg will be randomized to receive a shunt or not receive a
shunt.

Exclusion Criteria:

- Patients that will be excluded are those who present for a redo CEA, have had a
coronary artery bypass graft (CABG), permanent stroke, and or a contralateral artery
total occlusion of > 30%.

- Finally, consented patients with a stump pressure of <= 50 mm Hg will be excluded from
the study and receive standard of care.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All
Health Condition(s) or Problem(s) studied
Stenoses, Carotid Artery
Intervention(s)
Procedure: Carotid endarterectomy with routine shount
Procedure: Carotid endarterectomy with selective shunt
Primary Outcome(s)
Overall Perioperative Complications Between Selective vs. Routine Shunting. [Time Frame: Within 30 days of enrollment]
Secondary Outcome(s)
Secondary ID(s)
06-11-1878
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 24/10/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00967486
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