Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Overall Perioperative Complications Between Selective vs. Routine Shunting.
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Routine Shunt
These patients are called routine as the routine method of carotid endarterectomy is used.
Intervention: Carotid endarterectomy with routine shount (Procedure)
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.
Intervention: Carotid endarterectomy with selective shunt (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ali AbuRahma
Ali Fawzi AbuRahma MD, Vascular Center of Excellence(CAMC Medical Staff - with admitting privileges).
CAMC Health System