Skip to main content
OpenTrials
Completed

NCT Number: NCT01184183

Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Stenosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vascular Center of Excellence

Charleston, West Virginia, 25304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Comparing Accuseal Vs. Bovine Pericardial in CEA

Procedure

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.

Primary outcomes

  1. The aim of this study is to evaluate the perioperative and long-term complications (thrombosis of the carotid artery, and the degree of restenosis of the patched artery as determined by duplex ultrasound evaluation).

    Time frame: within 30 days of operation,6 month, 1 year, 2 year, 3 year

Secondary outcomes

  1. We hypothesize that the Accuseal patch will have a longer hemostasis time but a lower associated stroke rate and a longer time to restenosis than the Bovine Pericardial patch.

    Time frame: within 30 days of operation,6 month, 1 year, 2 year, 3 year

Sponsors and collaborators

Lead sponsor

CAMC Health System

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 18, 2010
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.