Status:
COMPLETED
Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy
Lead Sponsor:
CAMC Health System
Conditions:
Coronary Stenosis
Eligibility:
All Genders
18-90 years
Brief Summary
Carotid Endarterectomy (CEA), surgical removal of the blockage in the neck artery, is the accepted management of choice for significant blockage of the carotid artery. Previous studies showed improved...
Detailed Description
This study will be a prospective, randomized, evaluation comparing the outcomes resulting from the use of two different patches (Accuseal vs Bovine Pericardial) used for CEA.Our proposed study will ev...
Eligibility Criteria
Inclusion
- Symptomatic patients with \>50% stenosis or Asymptomatic patients \>60% stenosis: i.e.: patients experiencing a neurological event(s) such as a trans-ischemic attack, cerebrovascular accident, amaurosis fugax, and/or a preoperative duplex ultrasound, magnetic resonance angiogram, or Angiogram indicative of severe \> 60% carotid artery stenosis.
Exclusion
- will be enforced for those less than 18 years of age, patients who for religious reasons can not accept a Bovine Pericardial patch and those with a combined procedure ie: coronary artery bypass graft (CABG) and CEA.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01184183
Start Date
September 1 2009
End Date
January 1 2012
Last Update
February 19 2020
Active Locations (1)
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1
Vascular Center of Excellence
Charleston, West Virginia, United States, 25304