M2S® and VQI® Carotid Artery Stent Registry™ Selected to Support CREST-2 Trial

Chicago, IL and West Lebanon, NH Jun 24, 2015 – M2S, Inc., a leader in providing clinical outcomes data, and the Society for Vascular Surgery’s Vascular Quality initiative® (SVS VQI) have been chosen by the principal investigators for the CREST-2 Randomized Control Trial (RCT) to collect procedural data and reports for this project. M2S, as the exclusive registry provider to the SVS VQI, will be contracting with sites for the associated CREST-2 Registry, which will monitor 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 will be 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.
CREST-2 is sponsored by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health. CREST-2 is designed to compare three different methods of stroke prevention to find the safest and most effective treatment for patients with narrowing of their carotid arteries. The stroke prevention methods include intensive medical management alone compared to intensive medical management in combination with a procedure to reopen the carotid artery for treatment of plaque buildup. The two procedures available in this study are carotid endarterectomy and carotid artery stenting. All participants will receive intensive medical management to help control their risk factors for stroke. CREST2 is co-sponsored by the Mayo Clinic and University of Maryland.
University of Maryland Training
Potential operators must undergo the web-based training program for the CREST-2 CAS protocol prior to enrolling patients into CREST-2 Registry. The University of Maryland Team will conduct these training and can be contacted at C2R@smail.umaryland.edu. Contact the University of Maryland team for any questions regarding Medicare reimbursement. More information may be found at:
http://www.cms.gov/Medicare/Medicare‐General‐Information/MedicareApprovedFacilitie/Carotid‐Artery‐Stenting‐CAS‐Investigational‐Studies.html
About the Vascular Quality Initiative (VQI)
The VQI was launched in 2011 by the Society for Vascular Surgery and M2S to improve the quality, safety, effectiveness and cost of vascular healthcare (www.svsvqi.org). It consists of web-based clinical data registries with real-time reporting capability that allows centers to anonymously compare their patients, processes of care and procedure outcomes with others. The VQI has important features that distinguish it from other national data registries, organized as a Patient Safety Organization, which allows providers to submit all outcomes without fear of reprisal. The VQI audits claims data submitted by members to insure that all procedures are submitted, to ensure 100% reporting. The VQI also includes one year follow-up to assess both early and late results. Finally, centers in VQI are organized into regional groups that meet semi-annually to discuss variation in regional processes and outcomes, in order to design and implement regional quality improvement projects. For more information about the VQI, visit www.svsvqi.org.