TransCarotid Revascularization Surveillance Project of the Society for Vascular Surgery Vascular Quality Initiative
Society for Vascular Surgery Patient Safety Organization
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.
Description
Background: Contemporary randomized trials of transfemoral carotid artery stenting (TF CAS) and carotid endarterectomy (CEA) have shown comparable long-term ipsilateral stroke prevention (\>30 days) but have consistently demonstrated higher periprocedural (\< 30 day) stroke rates, including contralateral stroke, compared with CEA, with the highest risk centered around "day zero". Potential etiologies for this excess risk likely relate to embolization during unprotected catheterization of the aortic arch and supraaortic vessels from a TF approach and/or suboptimal distal embolic protection dur…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 Criteria: * Patients who have received a previous stent in the target artery.
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
Location
- Society for Vascular Surgery Patient Safety OrganizationChicago, Illinois