CREST 2

The CREST-2 Companion Registry

CREST 2 [NCT02240862]

Description:  The objective of the CREST-2 Registry 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 performed by adequately experienced and skilled interventionists. Interventionists' eligibility will be determined by the multi-specialty CREST-2 Interventional Management Committee. Patient eligibility will include patients with conventional or high risk, symptomatic and asymptomatic carotid artery disease. Patients will be followed for the occurrence of post-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 individual interventionist safety and quality results from the CREST-2 Registry will help guide selection of interventionists for participation in the CREST-2 randomized clinical trial. Enrollment into the CREST-2 Registry will begin in 2014 and continue until publication of the primary results from the CREST-2 randomized clinical trial.

Device: Carotid Artery Stent

Primary Investigator: Bulas

Drug/Device Information
CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials.
One trial will assess treatment differences between intensive medical management alone compared to CEA plus intensive medical management.
The parallel trial will assess treatment differences between intensive medical management alone compared to CAS plus intensive medical management
Patients will be selected for either the CEA vs. intensive medical management trial or the CAS vs. intensive medical management trial based upon eligibility criteria for CEA or CAS
Randomized to receive revascularization plus intensive medical management (CAS or CEA) versus intensive medical management alone (MEDICAL)
The National Institute of Neurological Disorders and Stroke (NINDS)
Major Inclusion and Exclusion
Must be ≥ 35 years old with ≥ 70% carotid stenosis and must be treatable with CEA, CAS, or either procedures (asymptomatic)
No medical history of stroke or TIA ipsilateral to the stenosis within 180 days of randomization or previous ipsilateral CEA or CAS
No Platelet count <100,000, uncorrected INR >1.5, history of heparin-induced thrombocytopenia or creatinine =2.5(GFR =50)
No anticoagulation with Phenprocoumon (Marcumar), warfarin, or a direct thrombin inhibitor, or anti-Xa agents
No chronic atrial fibrillation, EF <30% or admission for heart failure in prior 6 months or known malignancy (other than basal cell non-melanoma skin cancer).
Those patients with prior treatment and no recurrence for >5 years are eligible for enrollment.