Monitoring the safety and effectiveness of a new carotid artery procedure
Official title: TransCarotid Revascularization Surveillance Project of the Society for Vascular Surgery Vascular Quality Initiative
Run by Society for Vascular Surgery Patient Safety Organization · NCT02850588 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60000 (estimated) |
| Sponsor | Society for Vascular Surgery Patient Safety Organization Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | November 1, 2016 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | October 7, 2022 |
| Trial ID | NCT02850588 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients undergoing TCAR or CEA who meet the surgical risk criteria set by CMS.
✕Probably not a fit
Patients who have previously received a stent in the target artery will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown comparable outcomes between TCAR and traditional methods, indicating potential for success with this approach.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Argon inhalation to protect thinking after carotid surgery.
This trial will test whether breathing an argon-oxygen mix during and after elective carotid surgery helps protect the brain and improve thinking while lowering the risk of postoperative delirium in adults.
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This trial will test whether placing a high‑coverage carotid stent, compared with medical therapy alone, reduces repeat embolic events in people who recently had symptoms from low‑grade (10–49%) carotid plaques with high‑risk features.
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Transcarotid Neuroprotection System with TCAR for Carotid Artery Disease
This registry tests how well the ENROUTE Transcarotid Neuroprotection System works in real-world patients with extracranial carotid artery disease who are treated with TCAR using Boston Scientific stents.
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Photon-counting CT vs conventional CT for carotid plaque in people with carotid artery stenosis
This study tests whether photon-counting CT gives clearer, more detailed pictures of carotid plaques compared with standard CT in patients with carotid artery stenosis to help characterize plaque features.
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Carotid artery stent for people with carotid narrowing who are high risk for surgery
This study will try a carotid artery stent system in adults with carotid artery narrowing who are considered high risk for carotid endarterectomy.
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Balloon guide catheter plus filter protection during carotid artery stenting
This trial tests whether adding a balloon guide catheter to the usual distal filter during carotid artery stenting reduces debris-related brain injury in adults with symptomatic (≥50%) or asymptomatic (≥70%) carotid stenosis scheduled for stenting.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.