Carotid Artery Disease Clinical Trial
— VQI-TCAROfficial title:
TransCarotid Revascularization Surveillance Project of the Society for Vascular Surgery Vascular Quality Initiative
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.
Status | Recruiting |
Enrollment | 60000 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Society for Vascular Surgery Patient Safety Organization | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Society for Vascular Surgery Patient Safety Organization |
United States,
Kwolek CJ, Jaff MR, Leal JI, Hopkins LN, Shah RM, Hanover TM, Macdonald S, Cambria RP. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2015 Nov;62(5):1227-34. doi: 10.1016/j.jvs.2015.04.460. — View Citation
Schermerhorn ML, Fokkema M, Goodney P, Dillavou ED, Jim J, Kenwood CT, Siami FS, White RA; SVS Outcomes Committee. The impact of Centers for Medicare and Medicaid Services high-risk criteria on outcome after carotid endarterectomy and carotid artery stenting in the SVS Vascular Registry. J Vasc Surg. 2013 May;57(5):1318-24. doi: 10.1016/j.jvs.2012.10.107. Epub 2013 Feb 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | One-year ipsilateral stroke or death | Any death or stroke in the territory of the treated carotid artery within one year of the carotid artery treatment | 1 year | |
Secondary | 30-day Stroke or death | Any stroke or death within 30 days of the carotid artery treatment | 30 days | |
Secondary | 30-day Stroke, death or myocardial infarction | Any stroke, death or myocardial infarction within 30 days of the carotid artery treatment | 30 days |
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