Status:
RECRUITING
The CREST-2 Registry
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Centers for Medicare and Medicaid Services
Conditions:
Carotid Artery Diseases
Eligibility:
All Genders
18-80 years
Brief Summary
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 ...
Detailed Description
Objectives: 1. Promote the rapid initiation and completion of enrollment in CREST-2 2. CAS will be performed by experienced operators 3. Clinical outcomes will be closely monitored 4. Prevent inappro...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Asymptomatic patients:
- Age ≥ 18 and ≤ 80 and any one of the following
- ≥70% stenosis, standard surgical risk for CEA
- ≥70% stenosis, high anatomic risk for CEA
- ≥70% stenosis, high physiologic risk for CEA
- Symptomatic patients:
- Symptomatic patients are defined by the following characteristics: Ipsilateral carotid Transient Ischemic Attack (TIA), with neurologic symptoms persisting less than 24 hours; Ipsilateral non-disabling stroke: Modified Rankin Scale (mRS) ≤ 3; and Ipsilateral transient monocular blindness: amaurosis fugax. \[Source: current Medicare NCD for CAS\]
- Age ≥ 18 and ≤ 80 and any one of the following
- ≥50% stenosis, standard surgical risk for CEA
- 50% to 69% stenosis, high anatomic risk for CEA
- 50% to 69% stenosis, high physiologic risk
- ≥70% stenosis, high anatomic and/or physiologic risk for CEA - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R
- ≥70% stenosis, post-CEA and -CAS - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R
- ≥70% stenosis, post-irradiation - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R
- Exclusion Criteria:
- Patients with any one of the following conditions are ineligible for enrollment in C2R
- NYHA Class IV CHF
- COPD on chronic continuous oxygen therapy
- Severe (Class Childs D) liver failure
- End-stage renal failure requiring dialysis
- Cancer with metastatic spread and/or undergoing active chemotherapeutic treatment
- Any dementia considered greater than "mild"
Exclusion
Key Trial Info
Start Date :
February 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
8000 Patients enrolled
Trial Details
Trial ID
NCT02240862
Start Date
February 1 2015
End Date
January 31 2026
Last Update
January 27 2025
Active Locations (1)
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1
University of Maryland - Administrative Center
Baltimore, Maryland, United States, 21201