CREST 2 Registry
A new registry will oversee the credentialing process for physicians and clinical centers interested in performing carotid artery stenting as part of the CREST-2 clinical trial. Dr. Brajesh K. Lal at the University of Maryland School of Medicine is the leader of this national CREST-2 Registry, known as C2R.
The C2R will evaluate hospitals and physicians across the country for their ability to perform carotid artery stenting. Committees within C2R will identify clinical centers and doctors that have the quality, resources, expertise, and clinical volume to be high-quality performers of carotid stenting. The University of Maryland was a natural leader for this registry based on its experience performing carotid stenting on appropriate patients throughout the mid-Atlantic.
Background on C2R
A CMS coverage decision in 2005 made carotid artery stenting (CAS) available to a small subset of very high-risk patients with carotid artery stenosis. The vast majority of carotid occlusive disease however, exists in an asymptomatic, standard surgical risk patient population. As CREST and other industry-sponsored post-marketing registries concluded enrollment, the number of CAS procedures performed in the U.S. declined considerably, posing a challenge for quality enrollment in future clinical trials for CAS best practices.
The C2R was designed to be a response to this challenge, serving as a physician-monitored avenue to help foster verification of qualified physicians and centers that are able to perform high-quality carotid artery stenting in the more common group of patients with carotid stenosis. New policies from CMS allow coverage for such patients, provided their treating physician has been credentialed by University of Maryland and is participating in the C2R.
Goals of C2R
Ensure that CAS is performed by adequately skilled and experienced operators
Prevent inappropriate use of CAS outside of C2R
Closely monitor, and hence improve, clinical outcomes of C2R patients
Enrolling in CREST-2 Registry (C2R)
The C2R uses a detailed system to evaluate hospitals and physicians from across the country. Resources were developed to submit information about the procedure that will be reviewed and evaluated in order to monitor quality and outcomes. For this purpose, the C2R will leverage the existing data-collection infrastructure of the Society of Vascular Surgery’s Vascular Quality Initiative and the American College of Cardiology’s National Cardiovascular Data Registry. Centers that are not able to maintain quality will have their credentialing withdrawn.
Clinical centers that are currently certified by CMS to provide CAS for high-risk symptomatic patients may apply for potential participation in C2R.
Sites must first express an interest to join C2R by contacting Brajesh Lal: firstname.lastname@example.org. They will then be asked to complete a Site Selection Questionnaire to be reviewed by the Site Selection Committee. Once a site is approved, the prospective stent operators must submit their prior carotid stenting cases for review by the Interventional Management Committee (IMC). Once the review is complete, University of Maryland will issue them a Green Light Letter to permit initiation of enrollment in C2R.
For more information, contact Brajesh Lal at email@example.com.