Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy

This study is currently recruiting participants.
Verified February 2013 by CAMC Health System
Sponsor:
Information provided by (Responsible Party):
Patrick Stone, MD, CAMC Health System
ClinicalTrials.gov Identifier:
NCT01184183
First received: August 17, 2010
Last updated: February 18, 2013
Last verified: February 2013

August 17, 2010
February 18, 2013
September 2009
July 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01184183 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy
Prospective Randomized 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Coronary Stenosis
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.

  • Accuseal patch
    Intervention: Procedure: Comparing Accuseal Vs. Bovine Pericardial in CEA
  • Bovine Pericardial patch
    Intervention: Procedure: Comparing Accuseal Vs. Bovine Pericardial in CEA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
Yes
Contact: Patrick Stone, M.D. 304-388-8250 ext 9901
United States
 
NCT01184183
09-02-2136
No
Patrick Stone, MD, CAMC Health System
CAMC Health System
Not Provided
Principal Investigator: Patrick Stone, M.D. Vascular Center of Excellence(CAMC Medical Staff - with admitting privileges)
CAMC Health System
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP