Selective Versus Routine Shunting in Carotid Endarterectomy Patients
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|ClinicalTrials.gov Identifier: NCT00967486|
Recruitment Status : Completed
First Posted : August 28, 2009
Results First Posted : October 24, 2013
Last Update Posted : October 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Stenoses, Carotid Artery||Procedure: Carotid endarterectomy with routine shount Procedure: Carotid endarterectomy with selective shunt||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
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
- Overall Perioperative Complications Between Selective vs. Routine Shunting. [ Time Frame: Within 30 days of enrollment ]perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|