SVS VQI TransCarotid Revascularization Surveillance Project

Conditions

• Carotid Artery Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Transcarotid artery revascularization — PROCEDURE
  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
• Carotid endarterectomy — PROCEDURE
  Removal of carotid atherosclerotic plaque (endarterectomy) via a surgical incision in the neck

Study Details

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.

Key Dates

Start date

Nov 1, 2016

Status verified

Oct 2022

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

60,000 participants (estimated)

Arms

• Arm: 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
• Arm: 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

Primary Outcome Measure

One-year ipsilateral stroke or death [ Time Frame: 1 year ]

Central Contacts

• James Wadzinski
  312-334-2311
  [email protected]

Locations (1)

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