Selective Versus Routine Shunting in Carotid Endarterectomy Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ali AbuRahma, CAMC Health System
ClinicalTrials.gov Identifier:
NCT00967486
First received: August 27, 2009
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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 Intervention
Stenoses, Carotid Artery
Procedure: Carotid endarterectomy with routine shount
Procedure: Carotid endarterectomy with selective shunt

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure

Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • Overall Perioperative Complications Between Selective vs. Routine Shunting. [ Time Frame: Within 30 days of enrollment ] [ Designated as safety issue: No ]
    perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure.


Enrollment: 200
Study Start Date: December 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00967486

Locations
United States, West Virginia
(Vascular Center of Excellence)
Charleston, West Virginia, United States, 25304
Sponsors and Collaborators
CAMC Health System
Investigators
Principal Investigator: Ali F AbuRhama, M.D. CAMC Medical Staff - with admitting privileges
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: 06-11-1878
Study First Received: August 27, 2009
Results First Received: July 31, 2012
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014