Selective Verus Routine Shunting in Carotid Endarterectomy Patients
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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 |
- 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 ]
- 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 |
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| United States, West Virginia | |
| (Vascular Center of Excellence) | |
| Charleston, West Virginia, United States, 25304 | |
| 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 May 22, 2013