Clinical Trial: SVS VQI TransCarotid Revascularization Surveillance Project

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: TransCarotid Revascularization Surveillance Project of the Society for Vascular Surgery Vascular Quality Initiative

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.

Detailed Summary:

Background:

Contemporary randomized trials of transfemoral carotid artery stenting (TF CAS) and carotid endarterectomy (CEA) have shown comparable long-term ipsilateral stroke prevention (>30 days) but have consistently demonstrated higher periprocedural (< 30 day) stroke rates, including contralateral stroke, compared with CEA, with the highest risk centered around "day zero". Potential etiologies for this excess risk likely relate to embolization during unprotected catheterization of the aortic arch and supraaortic vessels from a TF approach and/or suboptimal distal embolic protection during CAS. TransCarotid Artery Revascularization (TCAR) combines the surgical principles of neuroprotection with minimally invasive endovascular techniques to treat stenosis in the carotid artery. It involves surgical exposure and clamping of the proximal common carotid artery with continuous carotid blood flow reversal via an extracorporeal arteriovenous shunt from the target carotid artery to a femoral vein, during which carotid bifurcation/internal carotid artery stenting is performed. Thus, TCAR avoids catheter manipulation in the aortic arch and emulates the "clamp and backbleed" method of neuroprotection during CEA, but differs from CEA in that the carotid artery is accessed through a smaller, supra-clavicular incision below the main plexus of cranial nerves. Further, the direct transcarotid approach allows the use of larger bore sheaths and tubing to achieve higher reverse carotid artery flow rates than is possible with smaller transfemoral catheters.

Published TCAR Data:

The initial study of TCAR in patients deemed to be at high risk for complications from CEA have shown that TCAR appears to provide superior stroke and death outcomes when compared to prior
Sponsor: Society for Vascular Surgery Patient Safety Organization

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Society for Vascular Surgery Patient Safety Organization

Dates:
Date Received: July 22, 2016
Date Started: November 2016
Date Completion: December 2024
Last Updated: February 7, 2017
Last Verified: July 2016