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Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy

NCT01184183 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-02-19

No results posted yet for this study

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.

Conditions

  • Coronary Stenosis

Interventions

PROCEDURE

Comparing Accuseal Vs. Bovine Pericardial in CEA

Accuseal patch - The Goretex Company has since designed a new patch, "the Accuseal," which is marketed as decreasing the intra-operative time (i.e, having a short hemostasis time) without affecting the perioperative stroke rate. Bovine Pericardial patch - The Bovine Pericardial patch has been used for nearly two decades, since the late 1990s. However, studies based on retrospective review of data in which patients received the Bovine Pericardial patch, reported the clinical outcomes post-operative stroke, death, time to hemostasis and recurrent restenosis.

Sponsors & Collaborators

  • CAMC Health System

    lead OTHER

Principal Investigators

  • Patrick Stone, M.D. · Vascular Center of Excellence(CAMC Medical Staff - with admitting privileges)

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01184183 on ClinicalTrials.gov