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Home / Quality Improvement / Device Surveillance & Evaluation


device surveillance & Evaluation

The Executive Committee approves Charters related to Industry projects and the associated Steering Committee activities.  Each Steering Committee has a Charter which includes objectives and endpoints, the responsibilities of the Steering Committee and the Conflict of Interest policies.

Typically, the role of the Steering Committee is overall responsibility for oversight of this quality improvement project. Specific responsibilities of the Steering Committee will include:

  • Monitor the execution and conduct of the industry project
  • Address and resolve study related scientific issues requiring their expertise, as determined by the Steering Committee chairperson;
  • Assist in development of study protocol;
  • Assist in the periodic review of data submission forms;
  • Assist with communications to ensure 1-year follow-up from participating sites
  • Monitor the progress of the project, including the review of non-identifiable datasets;
  • Address and resolve study related scientific and clinical issues/questions requiring their expertise;
  • Approve or author the primary scientific publication reporting the study results;
  • Approve the formation of Steering Committee writing groups, focused on the primary and secondary goals
  • Provide oversight and review for approved RAC studies outside of the study’s primary and secondary research objectives;
  • Make a final decision on submission for publication in a scientific journal

TCAR Surveillance Project

The TCAR Surveillance Project is designed to obtain more data about real-world outcomes of TCAR in comparison with CEA as performed by centers participating in the Vascular Quality Initiative (VQI). The TCAR Surveillance Project is directed by an SVS PSO Steering Committee that will make periodic analyses of data collected in the VQI CAS and CEA Registries.

The TCAR Surveillance Project was evaluated by the US Food and Drug Administration (FDA) and found scientifically valid and clinically relevant. Based on this, reimbursement for TCAR procedures performed by centers participating in the VQI TCAR Surveillance Project was approved on Sept. 1, 2016, by the Centers for Medicare and Medicaid Services (CMS) under the current National Coverage Determination.

Related Documents

crest-2 Randomized controlled trial

SVS VQI been chosen by the principal investigators for the CREST-2 Randomized Control Trial (RCT) to collect procedural data and reports for this project. M2S will be contracting with sites for the associated CREST-2 Registry, monitors volumes of carotid artery stent (CAS) procedures performed by potential CREST-2 interventionists until they achieve the minimum volume and quality to join the CREST-2 RCT. The SVS VQI CAS Registry is already providing this support to VQI members who intend to participate in CREST-2, through current or previously entered cases. Centers with interventionists who wish to participate in CREST-2 but are not yet members of SVS VQI may join the CAS Registry. Retrospective procedure entry as far back as September 17, 2014 can be reported for this project.

After sites are approved for the RCT, they will be required to continue to enter data into the VQI CAS Registry for patients who undergo CAS but are not included in the RCT. Participation in CREST-2 Registry and RCT allows sites to be reimbursed by CMS for CAS procedures in asymptomatic patients or lower risk symptomatic patients for whom Medicare coverage is not otherwise available

About the CREST-2 Trial

The CREST-2 Trial goals are to compare medically managed patients versus Carotid Endarterectomy and to compare medically managed patients versus carotid artery stent procedure. CREST-2 will enroll a maximum of 2,480 participants at 120 medical centers across the United States and Canada. The physicians are chosen to participate in CREST-2 based on their previous experience and are skilled at performing the procedure, based on a rigorous credentialing process which includes evaluating results from the CREST-2 Registry.

svs vqi Annual Report

The latest SVS VQI Annual Report is available for viewing! You can review the news and highlights of the past year by clicking below to access