The CREST-2 Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Maryland, Baltimore

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

8,000 Participants
are divided into 1 treatment group

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