Selective Versus Routine Shunting in Carotid Endarterectomy Patients
Primary Purpose
Stenoses, Carotid Artery
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carotid endarterectomy with routine shount
Carotid endarterectomy with selective shunt
Sponsored by
About this trial
This is an interventional diagnostic trial for Stenoses, Carotid Artery
Eligibility Criteria
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.
Sites / Locations
- (Vascular Center of Excellence)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Routine Shunt
Selective Shunt
Arm Description
These patients are called routine as the routine method of carotid endarterectomy is used.
These patients are selectively used for shunting or not shunting based on systolic pressure < 40mmHg. This group is further used as subgroup analysis.
Outcomes
Primary Outcome Measures
Overall Perioperative Complications Between Selective vs. Routine Shunting.
perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00967486
Brief Title
Selective Versus Routine Shunting in Carotid Endarterectomy Patients
Official Title
Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CAMC Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenoses, Carotid Artery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine Shunt
Arm Type
Active Comparator
Arm Description
These patients are called routine as the routine method of carotid endarterectomy is used.
Arm Title
Selective Shunt
Arm Type
Active Comparator
Arm Description
These patients are selectively used for shunting or not shunting based on systolic pressure < 40mmHg. This group is further used as subgroup analysis.
Intervention Type
Procedure
Intervention Name(s)
Carotid endarterectomy with routine shount
Intervention Type
Procedure
Intervention Name(s)
Carotid endarterectomy with selective shunt
Primary Outcome Measure Information:
Title
Overall Perioperative Complications Between Selective vs. Routine Shunting.
Description
perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure.
Time Frame
Within 30 days of enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali F AbuRhama, M.D.
Organizational Affiliation
CAMC Medical Staff - with admitting privileges
Official's Role
Principal Investigator
Facility Information:
Facility Name
(Vascular Center of Excellence)
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Selective Versus Routine Shunting in Carotid Endarterectomy Patients
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