Monitoring the safety and effectiveness of a new carotid artery procedure
TransCarotid Revascularization Surveillance Project of the Society for Vascular Surgery Vascular Quality Initiative
This study is testing a new, less invasive carotid artery procedure to see if it is safer and more effective than the standard surgery for people with carotid artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Society for Vascular Surgery Patient Safety Organization Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT02850588 on ClinicalTrials.gov |
What this trial studies
The VQI TCAR Surveillance Project aims to evaluate the safety and effectiveness of TransCarotid Artery Revascularization (TCAR) compared to standard carotid endarterectomy (CEA) in patients with carotid artery disease. This observational study will track outcomes in patients undergoing these procedures at participating centers within the Society for Vascular Surgery Vascular Quality Initiative. By utilizing a minimally invasive approach with neuroprotection, the study seeks to reduce the risk of stroke associated with carotid artery interventions.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing TCAR or CEA who meet the surgical risk criteria set by CMS.
Not a fit: Patients who have previously received a stent in the target artery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective treatment options for patients with carotid artery disease.
How similar studies have performed: Previous studies have shown comparable outcomes between TCAR and traditional methods, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chicago, Illinois
- Society for Vascular Surgery Patient Safety Organization — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: James Wadzinski
- Email: jwadzinski@svspso.org
- Phone: 312-334-2311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.