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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
Sponsor:
Information provided by (Responsible Party):
Ali AbuRahma, CAMC Health System

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stenoses, Carotid Artery Procedure: Carotid endarterectomy with routine shount Procedure: Carotid endarterectomy with selective shunt Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, West Virginia
(Vascular Center of Excellence)
Charleston, West Virginia, United States, 25304
Sponsors and Collaborators
CAMC Health System
Investigators
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Principal Investigator: Ali F AbuRhama, M.D. CAMC Medical Staff - with admitting privileges
More Information
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Responsible Party: Ali AbuRahma, Ali Fawzi AbuRahma MD, Vascular Center of Excellence(CAMC Medical Staff - with admitting privileges)., CAMC Health System
ClinicalTrials.gov Identifier: NCT00967486    
Other Study ID Numbers: 06-11-1878
First Posted: August 28, 2009    Key Record Dates
Results First Posted: October 24, 2013
Last Update Posted: October 24, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases