Selective Verus Routine Shunting in Carotid Endarterectomy Patients

This study has been completed.
Sponsor:
Information provided by:
CAMC Health System
ClinicalTrials.gov Identifier:
NCT00967486
First received: August 27, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  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. The patients would be selectively randomized to shunt or no shunt placement based upon intraoperative measurement of a carotid artery stump pressure >=50 mmHg.


Condition Intervention
Stenoses, Carotid Artery
Procedure: Shunt or No 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:
  • The primary objective of this investigation is to determine through a prospectively randomized method whether a SP >= 50 mm Hg can be used as a threshold to indicate the need for selective carotid shunting during CEA under GA. [ Time Frame: Within 30 days of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A secondary objective is to document and measure the outcomes (death, minor stroke, major stroke, trans-ischemic attach (TIA)) that result from selective shunting. [ Time Frame: Within 30 days of enrollemnt ] [ Designated as safety issue: No ]

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: Shunt Procedure: Shunt or No Shunt
Comparing the shunt Vs. No shunt placement in Carotid procedures
Active Comparator: No Shunt Procedure: Shunt or No Shunt
Comparing the shunt Vs. No shunt placement in Carotid procedures

Detailed Description:

The significance extends to all surgeons who perform CEA 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, TIA) for patients undergoing a CEA with a SP of > 50 mm Hg using selective shunting.If the stump pressure is < 50 mm Hg the patient will receive standard of care (placement of a shunt) and excluded from the study.If the stump pressure is > 50 mm Hg the patient will be placed in the selective shunt arm and randomized to either have the CEA performed without the use of a shunt or with a shunt. All patients in the study, irrespective of treatment group will be followed post-operatively for 24 hours and 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
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 Fawzi AbuRahma MD, Vascular Center of Excellence(CAMC Medical Staff - with admitting privileges)
ClinicalTrials.gov Identifier: NCT00967486     History of Changes
Other Study ID Numbers: 06-11-1878
Study First Received: August 27, 2009
Last Updated: August 27, 2009
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 June 17, 2013