Recruiting

TCAR vs. Endarterectomy

Sponsor:

Society for Vascular Surgery Patient Safety Organization

Code:

NCT02850588

Conditions

Carotid Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcarotid artery revascularization

Carotid endarterectomy

Study Details

Brief 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.

Conditions

Carotid Artery Disease

Study ID

NCT02850588

Start date

Nov 1, 2016

Status verified date

Oct, 2022

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Transcarotid 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

Carotid endarterectomy

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

James Wadzinski

312-334-2311jwadzinski@svspso.org

Locations

Society for Vascular Surgery Patient Safety Organization

Recruiting

Chicago, Illinois, United States, 60611

Contacts

JAMES K Wadzinski

312-334-2311jwadzinski@svspso.org

More Information

Sponsor

Society for Vascular Surgery Patient Safety Organization

Last update posted

Oct 7, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Society for Vascular Surgery Patient Safety Organization on 2022-10-07.