Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy

Coronary Stenosis Clinical Trial

Official title: Prospective Randomized Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy

Status Completed

Clinical Trial 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 perioperative outcomes and prevention of recurrent blockage by the use of the patch to close the surgical incision in the artery. The ideal patch reduces bleeding and prevents recurrent blockage.This is looking at long-term results toward improvement with the use Accuseal patch than Bovine Patch.

Clinical Trial 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 evaluate the perioperative (within 30 days of operation) and long-term (6 month, 1 year, 2 year, 3 year) complications associated with the Accuseal and Bovine Pericardial patches. This will include thrombosis of the carotid artery, and the degree of recurrent plaque formation of the patched artery as determined by duplex ultrasound evaluation in the perioperative and long-term periods.Patients will be blinded to the type of patch they received.Survival analysis (Kaplan-Meier) (used in this case for time to the event analysis) will be used for time to restenosis, time to stroke, and time to late death. ;

Related Conditions & MeSH terms

• Coronary Stenosis

• NCT number: NCT01184183
• Study type: Observational
• Source: CAMC Health System
• Status: Completed
• Start date: September 2009
• Completion date: January 2012