TransCarotid Revascularization Surveillance Project of the Society for Vascular Surgery Vascular Quality Initiative
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY
The VQI TCAR Surveillance Project is designed to monitor the safety and effectiveness of stents placed directly into the carotid artery while reversing blood flow within the carotid artery to reduce stroke risk. It will compare this less-invasive surgical procedure with standard carotid endarterectomy in centers that participate in the Society for Vascular Surgery Vascular Quality Initiative.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• All patients undergoing TCAR or CEA both standard surgical risk and high surgical risk as defined by the CMS criteria published in the National Coverage Determination for Percutaneous Transluminal Angioplasty (20.7).
Locations
United States
Illinois
Society for Vascular Surgery Patient Safety Organization
RECRUITING
Chicago
Contact Information
Primary
James Wadzinski
jwadzinski@svspso.org
312-334-2311
Time Frame
Start Date: 2016-11-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60000
Treatments
TCAR treatment
All patients, both high risk and standard risk surgical patients undergoing transcarotid revascularization with a carotid stent during carotid artery flow reversal in hospitals that participate in the Carotid Artery Stent Registry of the Society for Vascular Surgery Patient Safety Organization
CEA treatment
All patients undergoing carotid endarterectomy in hospitals that participate in the Carotid Endarterectomy Registry of the Society for Vascular Surgery Patient Safety Organization
Related Therapeutic Areas
Sponsors
Leads: Society for Vascular Surgery Patient Safety Organization