Clinical trial NCT01184183: Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy
Official title: Prospective Randomized Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Stenosis
Keywords: Patch for Carotid Endarterectomy
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population includes Carotid Endarterectomy (CEA), surgical removal of the blockage in the neck artery patients.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
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).
timeFrame: within 30 days of operation,6 month, 1 year, 2 year, 3 year
Secondary outcomes:
measure: 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.
timeFrame: within 30 days of operation,6 month, 1 year, 2 year, 3 year
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Vascular Center of Excellence
state: West Virginia
Study officials:
affiliation: Vascular Center of Excellence(CAMC Medical Staff - with admitting privileges)
name: Patrick Stone, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.