Selective Versus Routine Shunting in Carotid Endarterectomy Patients

CAMC Health System

Status: Completed

Conditions: Stenoses, Carotid Artery

Treatments: Procedure: Carotid endarterectomy with selective shunt; Procedure: Carotid endarterectomy with routine shount

Study type: Interventional

Funder types: Other

Identifiers

NCT00967486

06-11-1878

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Routine Shunt

Active Comparator group

Description:

These patients are called routine as the routine method of carotid endarterectomy is used.

Treatment:

Procedure: Carotid endarterectomy with routine shount

Selective Shunt

Active Comparator group

Description:

These patients are selectively used for shunting or not shunting based on systolic pressure \< 40mmHg. This group is further used as subgroup analysis.

Treatment:

Procedure: Carotid endarterectomy with selective shunt