RecruitingNCT02850588

SVS VQI TransCarotid Revascularization Surveillance Project

TransCarotid Revascularization Surveillance Project of the Society for Vascular Surgery Vascular Quality Initiative


Sponsor

Society for Vascular Surgery Patient Safety Organization

Enrollment

60,000 participants

Start Date

Nov 1, 2016

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • 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).

Exclusion Criteria1

  • Patients who have received a previous stent in the target artery.

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Interventions

PROCEDURETranscarotid artery revascularization

Direct implantation of a stent into the carotid artery via a surgical incision in the neck combined with blood flow reversal in the carotid artery during stent placement

PROCEDURECarotid endarterectomy

Removal of carotid atherosclerotic plaque (endarterectomy) via a surgical incision in the neck


Locations(1)

Society for Vascular Surgery Patient Safety Organization

Chicago, Illinois, United States

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NCT02850588


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