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SVS VQI TransCarotid Revascularization Surveillance Project

ConditionCarotid Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociety for Vascular Surgery Patient Safety Organization

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients who have received a previous stent in the target artery.

Trial population

All patients who undergo TCAR and CEA in hospitals participating in the CAS or CEA registries of the SVS PSO

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Transcarotid artery revascularization

    Procedure/Surgery

    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/Surgery

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

Treatment groups

60,000 Participants
are divided into 2 treatment groups
Group A: TCAR treatment1 intervention
Group B: CEA treatment1 intervention

Trial outcomes

Primary outcomes

1

One-year ipsilateral stroke or death

Any death or stroke in the territory of the treated carotid artery within one year of the carotid artery treatment

Time frame
1 year

Secondary outcomes

1

30-day Stroke or death

Any stroke or death within 30 days of the carotid artery treatment

Time frame
30 days
2

30-day Stroke, death or myocardial infarction

Any stroke, death or myocardial infarction within 30 days of the carotid artery treatment

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Society for Vascular Surgery Patient Safety Organization

Lead sponsor

Source ClinicalTrials.gov
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