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Selective Versus Routine Shunting in Carotid Endarterectomy Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00967486
First Posted: August 28, 2009
Last Update Posted: October 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ali AbuRahma, CAMC Health System
August 27, 2009
August 28, 2009
July 31, 2012
October 24, 2013
October 24, 2013
December 2006
June 2009   (Final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT00967486 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Selective Versus Routine Shunting in Carotid Endarterectomy Patients
Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure
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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Stenoses, Carotid Artery
  • Procedure: Carotid endarterectomy with routine shount
  • Procedure: Carotid endarterectomy with selective shunt
  • Active Comparator: Routine Shunt
    These patients are called routine as the routine method of carotid endarterectomy is used.
    Intervention: 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.
    Intervention: Procedure: Carotid endarterectomy with selective shunt
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00967486
06-11-1878
No
Not Provided
Not Provided
Ali AbuRahma, CAMC Health System
CAMC Health System
Not Provided
Principal Investigator: Ali F AbuRhama, M.D. CAMC Medical Staff - with admitting privileges
CAMC Health System
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP