Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/2/2016 |
| Start Date: | September 2009 |
| End Date: | July 2013 |
| Contact: | Patrick Stone, M.D. |
| Phone: | 304-388-8250 |
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.
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.
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.
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.
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