Selective Versus Routine Shunting in Carotid Endarterectomy Patients
The project involves prospectively randomizing patients to either routine carotid shunting or selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA) to see the difference in post-op complications and occurence rates. Patients will be randomized to Routine shunt vs selective groups.
Stenoses, Carotid Artery
Procedure: Carotid endarterectomy with routine shount
Procedure: Carotid endarterectomy with selective shunt
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure|
- Overall Perioperative Complications Between Selective vs. Routine Shunting. [ Time Frame: Within 30 days of enrollment ] [ Designated as safety issue: No ]perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure.
|Study Start Date:||December 2006|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Routine Shunt
These patients are called routine as the routine method of carotid endarterectomy is used.
|Procedure: Carotid endarterectomy with routine shount|
Active Comparator: Selective Shunt
These patients are selectively used for shunting or not shunting based on systolic pressure < 40mmHg. This group is further used as subgroup analysis.
|Procedure: Carotid endarterectomy with selective shunt|
The significance extends to all surgeons who perform Carotid endarterectomy because of their desire to improve patient care by decreasing the overall perioperative complication rate of the procedure by selectively not shunting those patients who ideally do not require it and thus eliminating the attendant morbidity associated with it.
The hypothesis is that there will be no difference in patient outcomes (death, minor strokes, major strokes, transient ischemic attack (TIA)) for patients undergoing a Carotid endarterectomy with a SP of > 50 mm Hg using selective shunting.Patients will be randomized to Routine shunt vs selective groups. In Selective shunt, there will be subgroup analysis to measure % stenosis if the systolic pressure is < 40mmHg calling it as Shunt group. All patients in the study, irrespective of treatment group will be followed post-operatively from 24 hours to 30 days. The patient will be monitored and the following outcomes documented - death, minor stroke, major stroke, trans-ischemic attack (TIA).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967486
|United States, West Virginia|
|(Vascular Center of Excellence)|
|Charleston, West Virginia, United States, 25304|
|Principal Investigator:||Ali F AbuRhama, M.D.||CAMC Medical Staff - with admitting privileges|