Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy

CAMC Health System

Status: Completed

Conditions: Coronary Stenosis

Treatments: Procedure: Comparing Accuseal Vs. Bovine Pericardial in CEA

Study type: Observational

Funder types: Other

Identifiers

NCT01184183

09-02-2136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Accuseal patch

Treatment:

Procedure: Comparing Accuseal Vs. Bovine Pericardial in CEA

Bovine Pericardial patch

Treatment:

Procedure: Comparing Accuseal Vs. Bovine Pericardial in CEA