Actively Recruiting
The CREST-2 Registry
Led by University of Maryland, Baltimore · Updated on 2026-02-18
8000
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The CREST-2 Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- For asymptomatic patients: 70% or greater carotid artery narrowing with standard or high surgical risk
- For symptomatic patients: 50% or greater carotid artery narrowing with standard surgical risk
- For symptomatic patients: 50% to 69% carotid artery narrowing with high anatomic or physiologic surgical risk
- For symptomatic patients: 70% or greater carotid artery narrowing with high anatomic and/or physiologic surgical risk
- Symptomatic defined as ipsilateral transient ischemic attack (TIA) with symptoms lasting less than 24 hours, non-disabling stroke with Modified Rankin Scale 3 or less, or transient monocular blindness (amaurosis fugax)
You will not qualify if you...
- New York Heart Association (NYHA) Class IV congestive heart failure (CHF)
- Chronic obstructive pulmonary disease (COPD) requiring continuous oxygen therapy
- Severe liver failure classified as Childs Class D
- End-stage kidney failure requiring dialysis
- Cancer with metastasis or undergoing active chemotherapy
- Dementia worse than mild degree
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Maryland - Administrative Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
K
Kimberlly A Castro-Roberts, MBA, CCRC
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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