Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy

NCT01184183 | Completed

• 1 other identifier: 09-02-2136
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 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

Keywords

Patch for Carotid Endarterectomy

Outcome Measures

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).

  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.

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

Study Arms (2)

Accuseal patch

Procedure: Comparing Accuseal Vs. Bovine Pericardial in CEA

Bovine Pericardial patch

Procedure: Comparing Accuseal Vs. Bovine Pericardial in CEA

Interventions

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.

Accuseal patch; Bovine Pericardial patch

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population includes Carotid Endarterectomy (CEA), surgical removal of the blockage in the neck artery patients.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Vascular Center of Excellence

Charleston, West Virginia, 25304, United States

Location

Related Publications (1)

• Stone PA, AbuRahma AF, Mousa AY, Phang D, Hass SM, Modak A, Dearing D. Prospective randomized trial of ACUSEAL versus Vascu-Guard patching in carotid endarterectomy. Ann Vasc Surg. 2014 Aug;28(6):1530-8. doi: 10.1016/j.avsg.2014.02.017. Epub 2014 Feb 19.

  PMID: 24561207 RESULT

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Patrick Stone, M.D.

  Vascular Center of Excellence(CAMC Medical Staff - with admitting privileges)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Patrick Stone, M.D., Vascular Center of Excellence(CAMC Medical Staff - with admitting privileges).

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 18, 2010
• Study Start: September 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

US (1)