SVS VQI TransCarotid Revascularization Surveillance Project (VQI-TCAR)
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ClinicalTrials.gov Identifier: NCT02850588 |
Recruitment Status :
Recruiting
First Posted : August 1, 2016
Last Update Posted : October 7, 2022
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Condition or disease | Intervention/treatment |
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Carotid Artery Disease | Procedure: Transcarotid artery revascularization Procedure: Carotid endarterectomy |

Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 60000 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | TransCarotid Revascularization Surveillance Project of the Society for Vascular Surgery Vascular Quality Initiative |
Actual Study Start Date : | November 1, 2016 |
Estimated Primary Completion Date : | December 31, 2026 |
Estimated Study Completion Date : | December 31, 2027 |

Group/Cohort | Intervention/treatment |
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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
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Procedure: 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 |
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
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Procedure: Carotid endarterectomy
Removal of carotid atherosclerotic plaque (endarterectomy) via a surgical incision in the neck |
- One-year ipsilateral stroke or death [ Time Frame: 1 year ]Any death or stroke in the territory of the treated carotid artery within one year of the carotid artery treatment
- 30-day Stroke or death [ Time Frame: 30 days ]Any stroke or death within 30 days of the carotid artery treatment
- 30-day Stroke, death or myocardial infarction [ Time Frame: 30 days ]Any stroke, death or myocardial infarction within 30 days of the carotid artery treatment

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850588
Contact: James Wadzinski | 312-334-2311 | jwadzinski@svspso.org |
United States, Illinois | |
Society for Vascular Surgery Patient Safety Organization | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: JAMES K Wadzinski 312-334-2311 jwadzinski@svspso.org |
Study Chair: | Marc L Schermerhorn, MD | Society for Vascular Surgery Patient Safety Organization |
Publications:
Responsible Party: | Society for Vascular Surgery Patient Safety Organization |
ClinicalTrials.gov Identifier: | NCT02850588 |
Other Study ID Numbers: |
VQI TCAR |
First Posted: | August 1, 2016 Key Record Dates |
Last Update Posted: | October 7, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |