Stenoses, Carotid Artery Clinical Trial
Official title:
Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure
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.
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).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic