About this trial
The objective of C2R is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid artery stenting (CAS) performed by experienced and skilled interventionists. Interventionists' eligibility will be determined by a multi-specialty Interventional Management Committee (IMC). Patient eligibility will include patients with standard or high-risk, symptomatic or asymptomatic carotid artery disease. Patients will be followed for the occurrence of post-procedural complications. The primary safety and quality endpoint will be the occurrence of any stroke or death within the 30-day period following the stenting procedure. The safety and quality results from C2R will guide selection of interventionists for participation in the CREST-2 randomized clinical trial. Enrollment into C2R will begin in 2015 and continue until publication of the primary results of the randomized trial.
Eligibility criteria
Qualifiers
≥70% stenosis, standard surgical risk for CEA
≥70% stenosis, high anatomic risk for CEA
≥70% stenosis, high physiologic risk for CEA
≥50% stenosis, standard surgical risk for CEA
Disqualifiers
NYHA Class IV CHF
COPD on chronic continuous oxygen therapy
Severe (Class Childs D) liver failure
End-stage renal failure requiring dialysis
Trial design
Treatments tested in this trial
- Carotid Artery Stent
Treatment groups
Sponsors and collaborators
University of Maryland, Baltimore
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Centers for Medicare and Medicaid Services
Collaborator
Mayo Clinic
Collaborator
Society for Vascular Surgery
Collaborator
American College of Cardiology
Collaborator