CREST-2 Randomized Control 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 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 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.