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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
History of Changes
  Purpose

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.


Condition Intervention
Coronary Stenosis
 Procedure: Comparing Accuseal Vs. Bovine Pericardial in CEA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Randomized Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy

Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: September 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Accuseal patch 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.
Bovine Pericardial patch 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.

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184183

Contacts
Contact: Patrick Stone, M.D. 304-388-8250 ext 9901

Locations
United States, West Virginia
Vascular Center of Excellence Recruiting
Charleston, West Virginia, United States, 25304
Contact: Patrick Stone, M.D.     304-388-8250 ext 9901        
Sub-Investigator: Steven Hass, M.D.            
Sub-Investigator: Albier Mousa, M.D.            
Sub-Investigator: Ali F AbuRhama, M.D.            
Sponsors and Collaborators
CAMC Health System
Investigators
Principal Investigator: Patrick Stone, M.D. Vascular Center of Excellence(CAMC Medical Staff - with admitting privileges)
  More Information

No publications provided

Responsible Party: Patrick Stone, MD, Patrick Stone, M.D., Vascular Center of Excellence(CAMC Medical Staff - with admitting privileges)., CAMC Health System
ClinicalTrials.gov Identifier: NCT01184183     History of Changes
Other Study ID Numbers: 09-02-2136
Study First Received: August 17, 2010
Last Updated: February 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by CAMC Health System:
Patch for Carotid Endarterectomy

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013